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Recall Observatory FDA recall evidence

Device 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.

Z-2075-2012

July 13, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 62582
Status
Terminated
Classification
Class II
Quantity
4,420 sets
Official record key
device-enforcement:Z-2075-2012

Official wording

Reason: The float valve in the burette sticks to the burette wall and does not open or close properly.

Code information: list 12722-65, lot number 96-098-5H

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The float valve in the burette sticks to the burette wall and does not open or close properly.