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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 PlumSetsee related information
Date Initiated by FirmMay 06, 2005
Date PostedNovember 24, 2005
Recall Status1 Terminated 3 on November 29, 2005
Recall NumberZ-0195-06
Recall Event ID 31990
510(K)NumberK830014 K920736 K941214 
Product Classification Set, Blood Transfusion - Product Code BRZ
ProductLifeShield 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/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information ContactLuann M. Pendy, Ph.D.
224-212-4974
Manufacturer Reason
for Recall		Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
FDA Determined
Cause 2		Other
ActionHospira 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 Commerce17,184 units
DistributionNationwide including Puerto Rico, and internationally to Mexico and Australia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BRZ
510(K)s with Product Code = BRZ
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