Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000.
FDA device recall Z-0670-06 · posted 2006-03-21 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The catheter tubing included in the kit may break during removal.
- Action taken
- Each consignee was notified of the recall via recall letter dated 2/7/06, which requested that they destroy the affected lots on site. International accounts were notified via email.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEA
- Distribution
- Nationwide, Australia and Canada.
- Date initiated
- 2006-02-03
- Date posted
- 2006-03-21
- Date terminated
- 2007-06-04
- 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 |