—#119886

Product

List No. 14207-28; BLOOD SET; 200 Micron Filter, 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

FDA product code: BRZ — Set, Blood Transfusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K101677
Affected lot / code info: List Number: 14207-28; Lot Number: 962295H

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Hospira sent an Important Safety Information letter dated April 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exercise EXTREME CAUTION when using Hospira blood bags and to make sure that all instructions for use are included with the blood bag and their facility's protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag. Customers with issues were instructed to call Hospira at 1-800-441-4100 or email ProductComplaintsPP@hospira.com. Customers were asked to complete the attached replay formand return it to the fax number on the form. If customers distributed the product further they were instructed to notify their accounts that received the affected product and ask them to contact Stericycle at 1-866-608-3936 to receive a reply form. Customers with questions were instructed to contact Hospira at 1-800-441-4100. For questions regarding this recall call 224-212-2000.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.

Timeline

Recall initiated: 2013-04-01
Posted by FDA: 2013-08-05
Terminated: 2017-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119886. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.