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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Single Day Infusor 2 mL/h System

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  Class 2 Device Recall Baxter Single Day Infusor 2 mL/h System see related information
Date Initiated by Firm March 15, 2011
Date Posted May 05, 2011
Recall Status1 Terminated 3 on March 12, 2012
Recall Number Z-2146-2011
Recall Event ID 58181
510(K)Number K982102  
Product Classification Pump, infusion, elastomeric - Product Code MEB
Product Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP
The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications.
Code Information product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054
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		 Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.
FDA Determined
Cause 2		 Labeling mix-ups
Action Baxter Healthcare Corp. sent Urgent Product Recall letters dated March 15, 2011, via first class mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The accounts were requested to examine all of their inventory locations for both product code 2C1071KJP and 2C1073KJP, lot 10H054, and return the affected lot for replacement or credit. The accounts were also requested to complete the attached customer reply form listing the number of held for return, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Center for One Baxter at 1-800-422-9837.
Quantity in Commerce 3,696 units
Distribution Worldwide Distribution - USA including AL and the countries of Mexico and Spain
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 CORP.
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