Class 2 Device Recall Hospira LifeShield LatexFree 100 mL Burette Set

• Date Initiated by Firm: July 13, 2012
• Date Posted: July 25, 2012
• Recall Status: Terminated on November 28, 2016
• Recall Number: Z-2075-2012
• Recall Event ID: 62582
• 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 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: 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 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.