Recall Z-2075-2012
Hospira Inc. · initiated July 13, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: list 12722-65, lot number 96-098-5H
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 taken
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.
Details
- Recall number
- Z-2075-2012
- Initiated
- July 13, 2012
- Posted by FDA
- July 25, 2012
- Terminated
- November 28, 2016
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 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.
- Recalling firm
- Hospira Inc., Lake Forest, IL