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
Lift, Patient, Non-Ac-Powered - Product Code FSA
Cause
The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift.
Action
All affected end users were given a copy of the Customer Advisory Notice dated 1/30/03, during the Arjo salesmen visits to inspect the Minstrel lifts for the presence of the tension pin in the pivot bolt of the lift. The advisory informed the user of the incident where the spreader bar detached from the scale unit. The end user was requested to read the advisory and sign the bottom portion of it certifying that they read the advisory and that the Arjo salesman inspected their units for the presence of the tension pin, retaining a copy of the signed advisory notice and the inspeciton record.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Cause
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Action
A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
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
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Cause
Mislabeled product. the recalling firm received a complaint that a box of introcan safety catheters, (22g x 1 inch) contained mixed 18g catheters with the same lot number.
Action
The recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters.
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
Bandage, Elastic - Product Code FQM
Cause
Bandages labeled as "100% latex free" may contain latex. the wrapper was analytically tested by a private laboratory and found to contain latex.
Action
Recall letters & response forms were sent to the consignees on 5/10/04 via Certified Mail, Return Receipt Requested. On 5/24/04, a second recall letter & response form were mailed via Certified Mail to the 60 distributors that received the 2 additional lots being recalled.
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
Pump, Infusion, Insulin - Product Code LZG
Cause
Lack of assurance of sterility.
Action
The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.
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
Pump, Infusion, Insulin - Product Code LZG
Cause
Lack of assurance of sterility.
Action
The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.
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
Pump, Infusion, Insulin - Product Code LZG
Cause
Lack of assurance of sterility.
Action
The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.
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
Pump, Infusion, Insulin - Product Code LZG
Cause
Lack of assurance of sterility.
Action
The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.