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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira LifeShield LatexFree 150 mL Burette Set

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  Class 2 Device Recall Hospira LifeShield LatexFree 150 mL Burette Set see related information
Date Initiated by Firm November 10, 2011
Date Posted November 25, 2011
Recall Status1 Terminated 3 on December 15, 2016
Recall Number Z-0292-2012
Recall Event ID 60413
510(K)Number K101677  
Product Classification Set, administration, intravascular - Product Code FPA
Product Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; 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 19208-01

Intended use: for the administration of fluids
Code Information list 19208-01, lot number 83-107-5H
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
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		 Employee error
Action The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated November 10, 2011 to the customers of record via UPS on the same date. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-866-913-0667 or email to: hospira2530@stericycle.com; return affected product to Stericycle using the label provided with this 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 12,580 units
Distribution Worldwide distribution: USA (nationwide) including states of: Alabama, Alaska, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin, and internationally to Canada
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 = HOSPIRA, INC.
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