—#42245

Product

LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 11235-03

FDA product code: BRZ — Set, Blood Transfusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K830014, K865060, K920736, K941214
Affected lot / code info: list 11235-03, lots 270735H, 271635H

Why it was recalled

Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Nationwide, including Puerto Rico, and internationally to Australia, Mexico, Canada, Taiwan and Saudi Arabia.

Timeline

Recall initiated: 2005-09-29
Posted by FDA: 2005-11-15
Terminated: 2007-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42245. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.