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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield Primary Plumset

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  Class 2 Device Recall LifeShield Primary Plumset see related information
Date Initiated by Firm April 25, 2012
Date Posted May 04, 2012
Recall Status1 Terminated 3 on December 15, 2016
Recall Number Z-1491-2012
Recall Event ID 61680
510(K)Number K865060  
Product Classification Pump, infusion - Product Code FRN
Product LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12.

Product Usage: For administration of I.V. fluids.
Code Information list number 12030-12; lot number 89-029-5H; expiration date 01 JUN 2013
Recalling Firm/
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Ms. Ileana Quinones
Manufacturer Reason
for Recall
The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.
FDA Determined
Cause 2
Process control
Action Hospira, sent an "URGENT DEVICE RECALL" letter dated April 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product to return for credit. A Reply Form was enclosed for customers to complete and return via fax to 1-888-386-2073 or e-mail to: Hospira8503@stericycle.com. Contact Hospira Customer Care at 1-877-946-7747 for information regarding product availability.
Quantity in Commerce 145,875 sets
Distribution Worldwide Distribution - USA (nationwide) including the states of: Alabama, Colorado, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Pennsylvania, Wisconsin and the country of 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 = FRN and Original Applicant = ABBOTT LABORATORIES