Z-2075-2012 Class II Terminated
FDA device recall Z-2075-2012 was initiated by Hospira Inc. on Jul 13, 2012 and is designated Class II. Reason for recall: The float valve in the burette sticks to the burette wall and does not open or close properly. The recall status is terminated (terminated Nov 28, 2016). Affected quantity: 4,420 sets.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2012
- Initiation Date
- Jul 13, 2012
- Termination Date
- Nov 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,420 sets
Product Description
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.
Reason for Recall
The float valve in the burette sticks to the burette wall and does not open or close properly.
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.
Code Information
list 12722-65, lot number 96-098-5H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2075-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026