—#44130

Product

Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes 1M8560 and 1M8560R (pumps without drug library option); Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K940147
Affected lot / code info: all serial numbers

Why it was recalled

The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

Root cause (FDA determination)

Other

Action the firm took

Important Product Information letters dated 2/8/06 were sent to the AS40 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the delay in the detection of a downstream occlusion when the AS40 pump is used with large volume syringes at low flow rates. To minimize the occlusion detection times at low flow rates, Baxter recommended that the customers take the following actions: * Use the smallest possible syringe size for the volume of fluid to be delivered; * Select the low occlusion pressure setting to minimize the detection time; * Utilize infusion sets with thick-walled, small bore tubing to minimize the detection time; and * Always verify that the clamping device or stopcock is open in the fluid path prior to starting an infusion.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2006-02-08
Posted by FDA: 2006-03-07
Terminated: 2010-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44130. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.