Recall Z-2591-2010 ยท FRN Pump, Infusion
Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
| Date | Sep 28, 2010 (initiated Sep 2, 2010) |
| Status | Terminated |
| Reason | All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks. Some lots have a high failure rate associated with E2 errors. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent our Urgent Medical Device Recall Notices dated 7/12/2010 to Risk Managers and Materials Managers. The recall notice listed specific lots of PainPump2 and PainPump2 BlockAid that were under recall. Consignees were told to check stock for the recalled product, quarantine the product, and contact Stryker to arrange return shipment of the recalled product. On 9/2/2010 the firm sent out a second Urgent Medical Device Recall Notice. This notice expanded the scope of the recall to include all products distributed within the past 12 months. The shelf life of the product is 1 year - |
| Quantity | 54,568 all products |
| Distribution | Worldwide Distribution -- US, Canada, and Australia. |
| FDA record | Open on fda.gov |