Recall Z-0292-2012 ยท FPA Set, Administration, Intravascular
Hospira Inc.
Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; 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 19208-01 Intended use: for the administration of fluids
| Date | Nov 25, 2011 (initiated Nov 10, 2011) |
| 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 November 10, 2011 to the customers of record via UPS on the same date. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-866-913-0667 or email to: hospira2530@stericycle.com; return affected product to Stericycle using the label provided with this 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 represent |
| Quantity | 12,580 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: Alabama, Alaska, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101677 | HOSPIRA INFUSION BLOOD SETS Hospira, Inc., Aug 11, 2010 |