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.
FDA Recall Z-0817-2012 · Posted 2012-01-19
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Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2012-01-12
Date Terminated2016-08-29
Product Quantity960 units
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.
Firm 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: [email protected]. Please contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
Root Cause
Component design/selection
Distribution Pattern
Distributed in the states of North Carolina and Washington.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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