Recall Z-0923-2009 ยท FRN Pump, Infusion
Stryker Instruments Div. of Stryker Corporation
Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product Number 0500-166-025, REF 500-166-25. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly t
| Date | Feb 2, 2009 (initiated Nov 7, 2008) |
| Status | Terminated |
| Reason | There is a potential for the pump to overinfuse. |
| Root cause | Process control |
| Action | A "Medical Device Recall Notification" letter dated November 11, 2008 was issued to consignees. The letter identified the problem and instructed consignees to locate and destroy all affected products. Customers were also instructed to complete the enclosed Business Reply form and fax it to Stryker Instruments Regulatory Department at 866-521-2760. For questions regarding the recalled product, contact Stryker Instruments at 1-800-800-4236, extension 4056 or extension 3808. |
| Quantity | 118 boxes of all products. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042405 | PAINPUMP1; PAINPUMP2 Stryker Corp., Oct 14, 2004 |