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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield OmniFlow Primary I.V. Pump Set

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 Class 2 Recall
LifeShield OmniFlow Primary I.V. Pump Set
see related information
Date Posted February 27, 2007
Recall Status1 Terminated on March 24, 2008
Recall Number Z-0542-2007
Recall Event ID 37014
Premarket Notification
510(K) Number
K830014 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01
Code Information List 12163-01, lot 39-126-5H
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Ms. Luann M. Pendy
224-212-2000
Manufacturer Reason
for Recall
The tubing can separate from the set at the filter inlet post.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Hospira sent product recall letters dated 12/20/06 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts that the tubing can separate from the set at the filter inlet post due to an inadequate solvent bond. 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 7,656 sets
Distribution Nationwide.
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 = FPA and Original Applicant = ABBOTT LABORATORIES
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