Recall Z-0926-2009 ยท FRN Pump, Infusion
Stryker Instruments Div. of Stryker Corporation
Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000. The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management, the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bol
| Date | Jan 27, 2009 (initiated Nov 12, 2008) |
| Status | Terminated |
| Reason | The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication. |
| Root cause | Process design |
| Action | Consignees were notified via letter dated 11/12/08 and instructed to locate and destroy the affected lots. Customers were also instructed to complete and return the enclosed Business Reply form via fax (336-499-8603) to Stryker Instruments Regulatory Department. For questions regarding the recalled product, please contact Stryker Instruments at 1-800-800-4236, extension 3808 or extension 4056. |
| Quantity | 2,009 boxes |
| Distribution | Worldwide Distribution including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043466 | PAINPUMP2 Stryker Instruments, May 10, 2005 |