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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield LatexFree HEMA Blood PlumSet

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  Class 2 Device Recall LifeShield LatexFree HEMA Blood PlumSet see related information
Date Initiated by Firm May 06, 2005
Date Posted November 24, 2005
Recall Status1 Terminated 3 on November 29, 2005
Recall Number Z-0195-06
Recall Event ID 31990
510(K)Number K830014  K941214  K920736  
Product Classification Set, Blood Transfusion - Product Code BRZ
Product LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 11235-03
Code Information lot 25-086-5H
Recalling Firm/
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Luann M. Pendy, Ph.D.
Manufacturer Reason
for Recall
Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
FDA Determined
Cause 2
Action Hospira sent product recall letters dated 5/6/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possiblitiy of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
Quantity in Commerce 17,184 units
Distribution Nationwide including Puerto Rico, and internationally to Mexico and Australia
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BRZ and Original Applicant = ABBOTT LABORATORIES
510(K)s with Product Code = BRZ and Original Applicant = ABBOTT MFG., INC.