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U.S. Department of Health and Human Services

Class 1 Device Recall Plum Blood Set

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 Class 1 Recall
Plum Blood Set
see related information
Date Posted August 05, 2013
Recall Status1 Open
Recall Number Z-1855-2013
Recall Event ID 65689
Premarket Notification
510(K) Number
K101677 
Product Classification Set, Blood Transfusion - Product Code BRZ
Product List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 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
Code Information List Number: 14211-28; Lot Numbers: 052945H, 211855H
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Mr. Christopher Eustace
224-212-2000
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 288 units
Distribution Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BRZ and Original Applicant = HOSPIRA, INC.
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