—#73334

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K945942
Affected lot / code info: Product code 1M8550 serviced or repaired with part numbers AAS5001530RP, AAS5001531RP or A069160000RP between 11/1/07 and 7/29/08.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Worldwide Distribution --- USA including Puerto Rico, and countries of Canada and Korea.

Timeline

Recall initiated: 2008-09-05
Posted by FDA: 2008-10-21
Terminated: 2010-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73334. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.