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
FDA Recall Z-0195-06 · Posted 2005-11-24
Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeBRZ
Date Initiated2005-05-06
Date Terminated2005-11-29
Product Quantity17,184 units
Reason for Recall
Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide including Puerto Rico, and internationally to Mexico and Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.