Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI;
FDA device recall Z-1191-2009 · posted 2009-04-30 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
- Action taken
- A "Medical Device Recall Notification" letter dated February 11, 2009 was issued to consignees via phone, mail and/or email. The letter described the issue and instructed customers to discontinue use of the recalled product, destroy it according to instructions provided with the notification and return the "Business Reply Form" by fax to Stryker Instruments Regulatory Department, 1-866-521-2762. Further questions should be addressed to Stryker Instruments at 1-800-800-4236 extension 4086.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 24,675 pumps
- Distribution
- Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC
- Date initiated
- 2009-02-11
- Date posted
- 2009-04-30
- 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 |
|---|---|---|
| PAINPUMP2 (K043466) | Stryker Instruments | 2005-05-10 |