Recall Z-1541-2009 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point of Care Inc.
i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. Abbott Point of Care Inc., Abbott Park, IL 60064 The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon dioxide, and pH.
| 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 | 1136 boxes of 25 cartridges each |
| Distribution | Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER I-Stat Corp., May 10, 1994 |