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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield LatexFree Primary I.V. Set

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  Class 2 Device Recall LifeShield LatexFree Primary I.V. Set see related information
Date Initiated by Firm January 09, 2006
Date Posted February 08, 2006
Recall Status1 Terminated 3 on July 20, 2006
Recall Number Z-0505-06
Recall Event ID 34354
510(K)Number K832755  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.
Code Information list 19229-48, lot 36-073-5H
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Luann M. Pendy, PhD
224-212-2000
Manufacturer Reason
for Recall		 The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
FDA Determined
Cause 2		 Other
Action Hospira notified all of their customers who purchased these list numbers within the last year via letter dated 1/9/06, informing them of the diversion of the affected lots of product prior to being sterilized and that use of the lots could result in the delivery of fluids through a non-sterile pathway. They requested the accounts to check their stocks of the affected list numbers for the list lot numbers. If any of the lots are found in stock, they were requested to place them in quarantine immediately and call Hospira Customer Care at 1-877-946-7747.
Quantity in Commerce 48 sets
Distribution The lots were not released or distributed by Hospira
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 = FPA and Original Applicant = OMNI-GLOW, INC.
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