Recall Z-1540-2009 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point of Care Inc.
i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calc
| Date | Jun 18, 2009 (initiated Feb 23, 2009) |
| Status | Terminated |
| Reason | Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals. |
| Root cause | Packaging process control |
| Action | Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replace |
| Quantity | 1048 boxes of 25 cartridges each. |
| Distribution | Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan. |
| FDA record | Open on fda.gov |