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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Auto Syringe AS40 and AS40A Infusion Pumps

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  Class 2 Device Recall Baxter Auto Syringe AS40 and AS40A Infusion Pumps see related information
Date Initiated by Firm February 08, 2006
Date Posted March 07, 2006
Recall Status1 Terminated 3 on January 19, 2010
Recall Number Z-0599-06
Recall Event ID 34579
510(K)Number K940147  
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information all serial numbers
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER CORP.
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