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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
LifeShield Primary Plumset 		see related information
Date Posted May 04, 2012
Recall Number Z-1491-2012
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/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Ms. Ileana Quinones
224-212-2000
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.
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.
 
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