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FDAFDA · Food and drugs·Recall number Z-1854-2013

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

Published August 14, 2013 · Recall initiated: April 1, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Hospira Inc.
Distributor
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
Lot
List Number: 14210-28; Lot Number: 053835H
Risk classification
Class I
Area (FDA)
device
Country
United States

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