Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division
FDA device recall Z-0152-2009 · posted 2008-10-21 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.
- Action taken
- Urgent Product Recall letters dated 9/5/08 were sent on the same date via first class mail to the direct accounts, to the attention of the Director of Biomedical Engineering and Facility Risk Manager. If the account had device(s) that had been serviced by Baxter with a part affected by this action, a serial number list of the affected device(s) was provided with the notification. Customers were instructed to remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for the customer and they wish to perform self-service, the customers will also be provided with a Service Bulletin to provide instruction on replacement of the rear case assembly.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 509 units
- Distribution
- Worldwide Distribution --- USA including Puerto Rico, and countries of Canada and Korea.
- Date initiated
- 2008-09-05
- Date posted
- 2008-10-21
- Date terminated
- 2010-02-03
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTO SYRINGE(R) AS50 INFUSION PUMP (K945942) | Baxter Healthcare Corp | 1995-07-10 |