FDA Medical Device Recalls (openFDA)
Abbott Point of Care Inc.: Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.
- Recall number
- Z-0375-2008
- Recalling firm
- Abbott Point of Care Inc.
- Product
- Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.
- Status
- Terminated
- Initiated
- 2007-10-18
- Posted
- 2007-12-11
- Terminated
- 2008-07-18
- Reason
- Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
- 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.
- Quantity
- not on file
- Distribution
- Worldwide Distribution- including USA and country of Canada.
- Lot, serial or model codes
- Catalog Number: 06F09-01; 06F09-02 Lot Numbers: A07102A; A07124; A07138; D07117; D07119; D07120; and D07121.
- 510(k) numbers
- ["K001154","K894914","K912387"]
- PMA numbers
- not on file
- Product code
- JGS
- Firm FEI
- 2245578
- Firm city
- East Windsor
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28