Recall Z-1856-2013 ยท BRZ Set, Blood Transfusion
Hospira Inc.
List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
| Date | Aug 5, 2013 (initiated Apr 1, 2013) |
| Status | Terminated |
| Reason | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Root cause | Device Design |
| Action | Hospira sent an Important Safety Information letter dated April 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exercise EXTREME CAUTION when using Hospira blood bags and to make sure that all instructions for use are included with the blood bag and their facility's protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag. Customers with issues were instructed to call Hospira at 1-800-441-4100 or email |
| Quantity | 692,742 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING Hospira, Inc., Jan 7, 2011 |