U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Cause
Product has latex free symbol on package, yet contains latex components.
Action
On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Cause
Product has latex free symbol on package, yet contains latex components.
Action
On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are
included with livanova perfusion tube sets (pts) which were then distributed to customers.
Action
The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017.
The actions to be taken by the customer:
1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs.
2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure.
3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack.
4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack.
5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices.
6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Table, Radiographic, Tilting - Product Code IXR
Cause
There is unintended system movement or unwanted automatic movement of the tabletop.
Action
Siemens personal will install Host Software VA00F and Generator Host Software VE00D on affected Uroskop units. Update instructions were sent to users November 27,2002 and December 7, 2002.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Syringe, balloon inflation - Product Code MAV
Cause
Boston scientific (bsc) has received complaints for cracked trays on the encore device.
Action
The firm initiated their recall on 06/15/2017 by letter delivered by Fed Ex in the US, on 06/15-29/2017 in the Americas delivered by Courier, email and hand delivery, on 06/16/2017 in Europe by DHL, on 06/16-19/2017 in the Arab Emirates and East Asia by email and hand delivery and on 06/136/2017 in Japan by hand delivery.
In the notice, the firm described the problem and requested the following action:
1. Immediately check the inventory and identify whether there are products with UPNs and lot numbers affected by the recall.
2. Inspect the device tray in the area highlighted above. If any units with a cracked tray are identified in the supply, immediately discontinue use and segregate affected units in a secure location.
3. Arrange for the damaged units to be returned to Boston Scientific by completing the attached Reply Verification Tracking Form.
4. If no damage is identified, the device may be used as normal. Please complete and return the attached Reply Verification Tracking Form
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
intraocular lens surgery system - Product Code NCF
Cause
Some ora carts have the potential to return an incorrect iol power measurement during cataract surgery. this issue appears to have been caused by a software coding error that results in the lens coefficients for an iol model being downloaded from the alcon server in an incorrect order.
Action
The Market Action was initiated with Initial telephone contact to all affected customers starting June 30, 2017. These customers were informed of the issue, and advised not to use their ORA Carts for calculations with the lens model affected on their specific system. A confirmatory letter (Attachment 4) was also sent via overnight mail to these customers July 12, 2017. As of July 12, 2017, Alcon has identified 8 ORA Carts that are affected by the software coding error. Alcon has reset the IOL databases on all 8 of the identified affected ORA Carts.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
intraocular lens surgery system - Product Code NCF
Cause
Some ora carts have the potential to return an incorrect iol power measurement during cataract surgery. this issue appears to have been caused by a software coding error that results in the lens coefficients for an iol model being downloaded from the alcon server in an incorrect order.
Action
The Market Action was initiated with Initial telephone contact to all affected customers starting June 30, 2017. These customers were informed of the issue, and advised not to use their ORA Carts for calculations with the lens model affected on their specific system. A confirmatory letter (Attachment 4) was also sent via overnight mail to these customers July 12, 2017. As of July 12, 2017, Alcon has identified 8 ORA Carts that are affected by the software coding error. Alcon has reset the IOL databases on all 8 of the identified affected ORA Carts.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The cardan joint of the polarstem cardan could potentially fracture or functionally fail after multiple procedures.
Action
Smith & Nephew sent an Urgent Medical Device Recall Notice dated July 24, 2017, to all affected consignees. The firm notified their consignees by email and Fed Ex on 07/24/2017. Consignees have been asked to inspect inventory to locate and quarantine affected product. All consignees were asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew. Customers with questions were instructed to contact FieldActions@smith-nephew.com.
For questions regarding this recall call 978-749-1440.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Epidural anesthesia kit - Product Code OGE
Cause
Potential for partially incomplete seal of product, impacting sterility.
Action
Consignees were contacted 07/24/2017 via email and phone, notifying them of the recall. Consignees were asked to contact the recalling firm to report the number of affected product on hand. A second, updated recall notification was sent on 08/04/2017. Instructions included to examine inventory and quarantine any affected product, contact Epimed to arrange return/credit of the affected product, and complete and return the response form.