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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Recall Number Z-1854-2013
Classification Class I
Code Info List Number: 14210-28; Lot Number: 053835H
Product Distributed Qty 96 units
Reason For Recall It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.

Event Detail

Event Id 65689
Product Type Devices
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.