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U.S. Department of Health and Human Services

Class 2 Device Recall Fenwal

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  Class 2 Device Recall Fenwal see related information
Date Initiated by Firm July 16, 2003
Date Posted August 21, 2003
Recall Status1 Terminated 3 on June 29, 2004
Recall Number Z-1175-03
Recall Event ID 26772
510(K)Number K993120  
Product Classification Set, Blood Transfusion - Product Code BRZ
Product Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code Information catalog 4C6766, lot numbers UR140772 through UR166058. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.
Recalling Firm/
Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
FDA Determined
Cause 2
Action Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.
Quantity in Commerce 134,688 units
Distribution Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
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 = BRZ and Original Applicant = BAXTER HEALTHCARE CORP.