Recall Z-1866-2009 ยท MEB Pump, Infusion, Elastomeric
Stryker Instruments Div. of Stryker Corporation
Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-626-025.
| Date | Sep 4, 2009 (initiated May 14, 2009) |
| Status | Terminated |
| Reason | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| Root cause | Process control |
| Action | Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card. |
| Quantity | 28,755 of all pumps |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |