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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 Device Recall Hospira Blood Set, with 200 Micron Filtersee related information
Date Initiated by FirmJanuary 12, 2012
Date PostedJanuary 19, 2012
Recall Status1 Terminated 3 on August 29, 2016
Recall NumberZ-0817-2012
Recall Event ID 60869
510(K)NumberK101677 
Product Classification Set, administration, intravascular - Product Code FPA
ProductHospira 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 IL 60045-2579
For Additional Information ContactMs. 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		Component design/selection
ActionThe 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 Commerce960 units
DistributionDistributed in the states of North Carolina and Washington.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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