Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division
FDA device recall Z-0612-06 · posted 2006-03-16 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.
- Action taken
- Baxter sent Urgent Device Correction letters dated 2/7/06 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for the affected pumps to be susceptible to electro-static discharge, which could increase the potential to fail during use, causing the pump to stop infusing and issue an audible and visual alarm. The accounts were asked to immediately take the pump out of service, contact Baxter at 1-800-843-7867 to arrange for the return of the pumps in order to replace the non-conforming gasket, and complete and return the enclosed reply form confirming receipt of the letter. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 282 pumps
- Distribution
- Nationwide. Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kentucky, Louisiana, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas,
- Date initiated
- 2006-02-07
- Date posted
- 2006-03-16
- Date terminated
- 2008-03-24
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTO SYRINGE(R) AS50 INFUSION PUMP (K945942) | Baxter Healthcare Corp | 1995-07-10 |