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Terminated

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 Recall Z-0599-06 · Posted 2006-03-07

Recall StatusTerminated
Product CodeFRN
Date Initiated2006-02-08
Date Terminated2010-01-19
Product Quantity17,400 pumps

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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