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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 Device Recall LifeShield OmniFlow Primary I.V. Pump Set see related information
Date Initiated by Firm December 20, 2006
Date Posting Updated February 27, 2007
Recall Status1 Terminated 3 on March 24, 2008
Recall Number Z-0542-2007
Recall Event ID 37014
510(K)Number K830014  
Product Classification I.V. Pump Tubing Set - 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 IL 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
Other
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 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 = ABBOTT LABORATORIES
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