Z-0374-2008

Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No...

Name: Z-0374-2008 Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No...
Creator: Abbott Point of Care Inc.
Published: 2007-10-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-10-18 / Terminated / root cause: packaging

FDA source

Abbott Point of Care Inc. began a recall of Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ... on 2007-10-18. The reason FDA records is "Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0374-2008
Status: Terminated
Initiated: 2007-10-18
Posted: 2007-12-11
Terminated: 2008-07-18
Recalling firm: Abbott Medical
Product: Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
Distribution: Worldwide Distribution- including USA and country of Canada.
Product codes and lots: Catalog Number: 06F04-01; 06F04-02 Lot Numbers: A07110 and A07153.

Product code JGS

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)