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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira LifeShield LatexFree 100 mL Burette Set

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 Class 2 Recall
Hospira LifeShield LatexFree 100 mL Burette Set
see related information
Date Posted July 25, 2012
Recall Status1 Open
Recall Number Z-2075-2012
Recall Event ID 62582
Premarket Notification
510(K) Number
K101677 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.
Code Information list 12722-65, lot number 96-098-5H
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
Consumer Instructions No consumer action necessary
For Additional Information Contact Ms. Ileana Quinones
224-212-2000
Manufacturer Reason
for Recall
The float valve in the burette sticks to the burette wall and does not open or close properly.
FDA Determined
Cause 2
TRAINING: Employee Error
Action The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated July 13, 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; complete and return Reply Form via fax to 1-877-722-7019 or e-mail to: hospira4921@stericycle.com; return affected product to Stericycle using the label provided with the letter; and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.
Quantity in Commerce 4,420 sets
Distribution Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada.
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 = HOSPIRA, INC.
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