Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF
FDA device recall Z-0926-2009 · posted 2009-01-27 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 2,009 boxes
- Distribution
- Worldwide Distribution including USA and country of Canada.
- Date initiated
- 2008-11-12
- Date posted
- 2009-01-27
- Date terminated
- 2009-11-30
- 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 |