Recall Z-0817-2012 ยท FPA Set, Administration, Intravascular
Hospira Inc.
Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 14203-28. Intended use: for the administration of blood products.
| Date | Jan 19, 2012 (initiated Jan 12, 2012) |
| Status | Terminated |
| Reason | Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container. |
| Root cause | Component design/selection |
| Action | The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated January 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and immediately quarantine any affected product. Additionally, a Reply Form was attached for customers to complete and return via fax to 1-866-912-8410 or e-mail to: hospira2573@stericycle.com. Please contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall. |
| Quantity | 960 units |
| Distribution | Distributed in the states of North Carolina and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101677 | HOSPIRA INFUSION BLOOD SETS Hospira, Inc., Aug 11, 2010 |