Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 053
FDA device recall Z-1829-2009 · posted 2009-09-04 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
- Action taken
- Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 28,755 of all pumps
- Distribution
- Nationwide and Canada.
- Date initiated
- 2009-05-14
- Date posted
- 2009-09-04
- Date terminated
- 2010-01-20
- Location
- Kalamazoo, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOFUSER (K060258) | Ace Medical Us, LLC | 2006-05-30 |
| AUTOFUSER AMBULATORY INFUSION PUMP (K041585) | Algos, LC | 2004-08-26 |