Medical Device Recall: Z-0845-03

FDA Recalls dataset · Firm: Instrumentation Laboratory Co. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-03-07 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0845-03.

Recall Res Number
Z-0845-03
Recalling Firm / Manufacturer
Instrumentation Laboratory Co.
FEI Number
1217183
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-03-07
Date Posted
2003-05-20
Date Terminated
2012-05-23
Product Code
CHL
Event Number
25810
Product Quantity
16
Product Description GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Reason for Recall Incorrect bar code applied to cartridges could result in inaccurate pO2 value
Action Details IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.
Distribution Pattern CA, FL, NY, PA, TN,
Code Information / Serial Numbers Lot Number: 306355 Expires: 8/31/2003

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.