Recall Z-0135-06 ยท BRZ Set, Blood Transfusion
Hospira Inc.
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Inline Dual Channel Cassette, 2 Clave Ports and Option-Lok for use with Plum Series Infusers; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12259-02
| Date | Nov 15, 2005 (initiated Sep 29, 2005) |
| Status | Terminated |
| Reason | Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. |
| Root cause | Other |
| Action | Hospira sent product recall letters dated 9/29/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possibility of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lots, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement. |
| Quantity | 432,270 sets |
| Distribution | Nationwide, including Puerto Rico, and internationally to Australia, Mexico, Canada, Taiwan and Saudi Arabia. |
| FDA record | Open on fda.gov |