—#43611

Product

LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K832755
Affected lot / code info: list 19229-48, lot 36-073-5H

Why it was recalled

The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

Root cause (FDA determination)

Other

Action the firm took

Hospira notified all of their customers who purchased these list numbers within the last year via letter dated 1/9/06, informing them of the diversion of the affected lots of product prior to being sterilized and that use of the lots could result in the delivery of fluids through a non-sterile pathway. They requested the accounts to check their stocks of the affected list numbers for the list lot numbers. If any of the lots are found in stock, they were requested to place them in quarantine immediately and call Hospira Customer Care at 1-877-946-7747.

Recalling firm

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

Distribution

Distribution pattern: The lots were not released or distributed by Hospira

Timeline

Recall initiated: 2006-01-09
Posted by FDA: 2006-02-08
Terminated: 2006-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.