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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Blood Set, with 200 Micron Filter

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 Class 2 Recall
Hospira Blood Set, with 200 Micron Filter
see related information
Date Posted January 19, 2012
Recall Status1 Open
Recall Number Z-0817-2012
Recall Event ID 60869
Premarket Notification
510(K) Number
K101677 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 14203-28. Intended use: for the administration of blood products.
Code Information list 14203-28, lot 96-146-5H
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Ms. Ileana Quinones
224-212-2000
Manufacturer Reason
for Recall
Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated January 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and immediately quarantine any affected product. Additionally, a Reply Form was attached for customers to complete and return via fax to 1-866-912-8410 or e-mail to: hospira2573@stericycle.com. Please contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
Quantity in Commerce 960 units
Distribution Distributed in the states of North Carolina and Washington.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = HOSPIRA, INC.
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