FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. Indicated for infusion via intravenous, intra-arterial, epidural or subcutaneous routes of administration.
- Recall number
- Z-0152-2009
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. Indicated for infusion via intravenous, intra-arterial, epidural or subcutaneous routes of administration.
- Status
- Terminated
- Initiated
- 2008-09-05
- Posted
- 2008-10-21
- Terminated
- 2010-02-03
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 509 units
- Distribution
- Worldwide Distribution --- USA including Puerto Rico, and countries of Canada and Korea.
- Lot, serial or model codes
- Product code 1M8550 serviced or repaired with part numbers AAS5001530RP, AAS5001531RP or A069160000RP between 11/1/07 and 7/29/08.
- 510(k) numbers
- ["K945942"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28