Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryk
FDA device recall Z-0923-2009 · posted 2009-02-02 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- There is a potential for the pump to overinfuse.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 118 boxes of all products.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-11-07
- Date posted
- 2009-02-02
- Date terminated
- 2009-12-01
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PAINPUMP1; PAINPUMP2 (K042405) | Stryker Corp. | 2004-10-14 |