Z-0504-06

Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake...

Name: Z-0504-06 Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake...
Creator: Hospira Inc.
Published: 2006-01-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-01-09 / Terminated / root cause: sterility

FDA source

Hospira Inc. began a recall of Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A on 2006-01-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0504-06
Status: Terminated
Initiated: 2006-01-09
Posted: 2006-02-08
Terminated: 2006-07-20
Recalling firm: Abbott Medical
Product: Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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 tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 1 set
Distribution: The lots were not released or distributed by Hospira
Product codes and lots: list 4602-58, lot 35-092-5H

Product code FPA

K830014Class IIHema - Nv Trans. Blood Filter 100/800Abbott Laboratories / cleared 1983-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)