FDA Recall Terminated

Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, continuous flush device and drip chamber; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.

Recall: Z-0506-06 · Initiated January 9, 2006

Recall

Recall Number
Z-0506-06
Event Number
34354
Firm
Hospira Inc.
FEI Number
3013319212
Product Code
FPA
Status
Terminated
Root Cause
Other
Initiated
January 9, 2006
Posted
February 8, 2006
Terminated
July 20, 2006
Address
275 N Field Dr, Lake Forest, IL, 60045-2579

Description

Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, continuous flush device and drip chamber; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.

Reason

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.

Action

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.

Distribution

The lots were not released or distributed by Hospira

Quantity

60 sets