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U.S. Department of Health and Human Services

Class 2 Device Recall Infusion Pump

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  Class 2 Device Recall Infusion Pump see related information
Date Initiated by Firm June 07, 2013
Date Posted June 27, 2013
Recall Status1 Terminated 3 on June 04, 2014
Recall Number Z-1609-2013
Recall Event ID 65364
510(K)Number K062457  
Product Classification Pump, infusion, elastomeric - Product Code MEB
Product Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device


Device Listing: D020871

Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.

Code Information Product Code: 2C1073KJP  Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Route 120 And Wilson Rd
Round Lake IL 60073-9799
For Additional Information Contact
847-270-5556
Manufacturer Reason
for Recall		 Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
FDA Determined
Cause 2		 Device Design
Action Baxter sent an Urgent Produd Recall notification letter dated June 13, 2013, to all affected consignees via USPS. The letter was accompanied by a Customer Reply Form and Affected Product List (table). The letter stated affected products, problem description, risk to health (or health risks), actions to be taken by customers/users and contact information. The recall notification instructs customers to segregate affected product from current inventory and contact Baxter for instructions to return affected product. Customers with questions were instructed to call Baxter at 1-800-437-5176, For questions regarding this recall call 847-270-5556.
Quantity in Commerce 601,230 total
Distribution Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.
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 = MEB and Original Applicant = BAXTER HEALTHCARE CORPORATION
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