Recall Z-0371-2008
Abbott Point of Care Inc. · initiated October 18, 2007
Product
Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
Codes / lots: Catalog Number: 06F08-01; 06F08-02 Lot Numbers: A07104; A07140; A07141; and D07114
Reason for recall
Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
FDA-determined cause: Packaging change control
Action taken
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.
Details
- Recall number
- Z-0371-2008
- Initiated
- October 18, 2007
- Posted by FDA
- December 11, 2007
- Terminated
- July 18, 2008
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Distribution
- Worldwide Distribution- including USA and country of Canada.
- Recalling firm
- Abbott Point of Care Inc., East Windsor, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0370-2008 | Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01…Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not… | 10/18/2007Terminated |
| Z-0372-2008 | Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No:…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | 10/18/2007Terminated |
| Z-0373-2008 | Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No:…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | 10/18/2007Terminated |
| Z-0374-2008 | Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | 10/18/2007Terminated |
| Z-0375-2008 | Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No:…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | 10/18/2007Terminated |