List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica

FDA device recall Z-1851-2013 · posted 2013-08-05 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

BRZ

Quantity affected

1,152 units

Distribution

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

Date initiated

2013-04-01

Date posted

2013-08-05

Date terminated

2017-05-24

Location

Lake Forest, IL

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