Recall Z-0195-06 ยท BRZ Set, Blood Transfusion
Hospira Inc.
LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 11235-03
| Date | Nov 24, 2005 (initiated May 6, 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 5/6/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possiblitiy 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 lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement. |
| Quantity | 17,184 units |
| Distribution | Nationwide including Puerto Rico, and internationally to Mexico and Australia |
| FDA record | Open on fda.gov |