FDA Recall Terminated

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.

Recall: Z-1541-2009 · Initiated February 23, 2009

Recall

Recall Number: Z-1541-2009
Event Number: 51211
Firm: Abbott Point of Care Inc.
FEI Number: 2245578
Product Code: CHL
Status: Terminated
Root Cause: Packaging process control
Initiated: February 23, 2009
Posted: June 18, 2009
Terminated: July 29, 2009
Address: 104 Windsor Center Dr, East Windsor, NJ, 08520

Description

Reason

Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

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 replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.

Distribution

Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.

Quantity

1136 boxes of 25 cartridges each