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.
Product may have wrong large product identification label with symbols on the box indicating a s90 vapr electrode instead of the vapr 3.5 hook electrode.
Action
The firm, Depuy Mitek, sent a "Medical Device Labeling Alert" letter dated March 14, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory to determine if any inventory of product code 227305 lot with the number M1108086 that is incorrectly labeled; review the following label information and the attached examples of correct and incorrect labels; and complete and return the Business Reply Form via fax to: 1-508-828-3750. To return the product call 1-877-379-4871 for an RGA and replacement product and return to DePuy Mitek, Attn: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324.
Contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-48
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 anspach effort, inc. in palm beach gardens, fl is recalling the foot control/foot pedal due to the foot control cable lacking the shield connection from the cable to the connector body.
Action
Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.
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 anspach effort, inc. in palm beach gardens, fl is recalling the foot control/foot pedal due to the foot control cable lacking the shield connection from the cable to the connector body.
Action
Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.
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
Wire, guide, catheter - Product Code DQX
Cause
Nipro medical corporation, miami, fl recalled their aqualiner hydrophilic guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Action
Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.
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
Wire, guide, catheter - Product Code DQX
Cause
Nipro medical corporation, miami, fl recalled their aqualiner hydrophilic guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Action
Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.
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
Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
Action
Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
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
Wire, guide, catheter - Product Code DQX
Cause
Nipro medical corporation, miami, fl recalled their aqualiner hydrophilic guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Action
Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.
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
Wire, guide, catheter - Product Code DQX
Cause
Nipro medical corporation, miami, fl recalled their aqualiner hydrophilic guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Action
Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.
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
Wire, guide, catheter - Product Code DQX
Cause
Nipro medical corporation, miami, fl recalled their aqualiner hydrophilic guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Action
Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.
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
Material, impression - Product Code ELW
Cause
The firm recalled the product because it may cure harder than expected within the
shelf life, which could result in a material that may be more difficult to remove. use of this product on
patients with loose teeth may result in possible tooth fracture or tooth extraction.
Action
Kerr Corporation sent "URGENT: MEDICAL DEVICE RECALL" letters to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. US, Canadian, and Rest of World consignees were notified via USPS 1st class mail on June 19, 2012, and Australian
consignees on July 5, 2012. Consignees were instructed to complete and return the Acknowledgement Form. Notification of the recall expansion was sent, via USPS 1st class mail, on February 21, 2012 to US, Canadian, Australia and European, consignees; however, once further investigation determined that all unexpired lots of the product were affected, the Alginot recall was expanded a second recall letter was sent to clarify that all lots of AlgiNot FS Volume recall and AlgiNot recall expansion are affected by this expanded
recall. Letters were mailed to US, Canadian and Rest of World (ROW) customers on June 19, 2012; Australian and European consignees were notified of the expansion on July 5, 2012.
All consignees were instructed to complete the Return Form to acknowledge the updated instructions for use and the added cautionary statement.
Consignees not responding are to be contacted at least three times via telephone/fax/e-mail as follow up on the recall.
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
Enzyme controls (assayed and unassayed) - Product Code JJT
Cause
Abbott point of care (apoc) has determined that for the cliniqa liquid qc cardiac marker control for i-stat level 1 (list #06f12-09; lot number 071039); i-stat level 2 (list #06f12-10; lot number 081039); and i-stat level 3 (list #06f12-11; lot number 091039) results may be generated below the lower value assignment range for some vials.
Action
The firm, Abbott Point of Care, Inc. (APOC), sent an "URGENT RECALL NOTICE" dated July 2012 via FED-EX on July 19, 2012. The recall notice identified the product, problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of the control lot numbers; return all unused controls on the enclosed Customer Reply Form; If another institution was provided the controls, provide a copy of this notice to them. Note: if any used vials gave acceptable product performance, a review of the cartridge performance and associated patient results is not necessary)
Note: APOC is shipping replacement products to customers facilities to minimize any disruption this might cause.
If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.
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
Somatic gene mutation detection system - Product Code OWD
Cause
It was identified that braf controls dispositioned as "internal use only" were incorrectly packaged into cobas 4800 braf v600 mutation test ce-ivd kit lot r03607 and released for distribution. two control batches manufactured during two process validation studies are involved:
pv7711: braf mutant (mut) control
pv0853: braf wild type (wt) control.
Action
Roche sent a Safety Board Notice - Product Bulletin 2012-013 on 31-Jul-2012 to affected customers. The notice identifed the affected product, description of situation and actios to be taken. Customers were instructed to discontinue use, quarantine and discard any remaining kits of the affected product in inventory. Customers were advised to contact their affiliate sales office for replacement. The notice states a new cobas 4800 BRAF V600 Mutation Test lot (R07749) is anticipated to be available on 03-Aug-2012. For questions call +01.908.253.7569.
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
Agent, absorbable hemostatic, collagen based - Product Code LMF
Cause
Surgiflo hemostatic matrix kit & surgiflo hemostatic matrix kit with thrombin have an issue within the packing process where a cut could potentially breach the double tyvek pouch of the packaging.
Action
Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory to determine if they have any of the affected product. Affected product should be returned for replacement to Stericycle using the enclosed pre-paid shipping label. Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative.
For questions regarding this recall call 877-384-4266.
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
Retractor, self-retaining, for neurosurgery - Product Code GZT
Cause
Vycor medical recalled their vbas (vycor viewsite brain access system) because an unidentified black fiber was found on the device.
Action
Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.
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
Agent, absorbable hemostatic, collagen based - Product Code LMF
Cause
Surgiflo hemostatic matrix kit & surgiflo hemostatic matrix kit with thrombin have an issue within the packing process where a cut could potentially breach the double tyvek pouch of the packaging.
Action
Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory to determine if they have any of the affected product. Affected product should be returned for replacement to Stericycle using the enclosed pre-paid shipping label. Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative.
For questions regarding this recall call 877-384-4266.
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.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
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
Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
Action
Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
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.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
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.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
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.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
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.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
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.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
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.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
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
Counter, differential cell - Product Code GKZ
Cause
There is a variation of reticulocyte counts between xe series (xe-2100, xe-5000) and xt-series (xt-2000i, xt-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the xe-series because of a low bias.
Action
Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate.
Any questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639.
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
Counter, differential cell - Product Code GKZ
Cause
There is a variation of reticulocyte counts between xe series (xe-2100, xe-5000) and xt-series (xt-2000i, xt-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the xe-series because of a low bias.
Action
Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate.
Any questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639.