Z-0599-06

Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and...

Name: Z-0599-06 Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and...
Creator: Baxter Healthcare Corp.
Published: 2006-02-08
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2006-02-08 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of 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... on 2006-02-08. The reason FDA records is "The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0599-06
Status: Terminated
Initiated: 2006-02-08
Posted: 2006-03-07
Terminated: 2010-01-19
Recalling firm: Baxter Healthcare Corporation
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.
Product code: FRN Pump, Infusion
Reason for recall: The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
FDA root cause: Other
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.
Quantity in commerce: 17,400 pumps
Distribution: Nationwide and Canada
Product codes and lots: all serial numbers

Product code FRN

K940147Class IIAuto Syringe As40a Infusion PumpBaxter Corp. / cleared 1994-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)