Recall Z-1825-2009 ยท MEB Pump, Infusion, Elastomeric
Stryker Instruments Div. of Stryker Corporation
Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, 1 x 2.5" standard catheter, sterile, Manufactured for Stryker Instruments, Kalamazoo, MI; REF 0531-200-001.
| 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 |