Recall Z-2075-2012 ยท FPA Set, Administration, Intravascular
Hospira Inc.
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 administr
| Date | Jul 25, 2012 (initiated Jul 13, 2012) |
| Status | Terminated |
| Reason | The float valve in the burette sticks to the burette wall and does not open or close properly. |
| Root 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 Cu |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101677 | HOSPIRA INFUSION BLOOD SETS Hospira, Inc., Aug 11, 2010 |