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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-1173-03
Recall Event ID 26772
510(K)Number K881321  
Product Classification Set, Transfer (Blood/Plasma) - Product Code KSB
Product Fenwal Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 55'', 170 to 260 Micron Filter, catalog 4C2100; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code Information catalog 4C2100, lot numbers UR110346 through UR123513. 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/
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		 There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
FDA Determined
Cause 2		 Other
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 133,008 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 = KSB and Original Applicant = BAXTER HEALTHCARE CORP.
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