i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated ox

FDA device recall Z-1541-2009 · posted 2009-06-18 · Terminated

Recall details

Recalling firm

Abbott Point of Care Inc.

Reason for recall

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

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

CHL

Quantity affected

1136 boxes of 25 cartridges each

Distribution

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

Date initiated

2009-02-23

Date posted

2009-06-18

Date terminated

2009-07-29

Location

East Windsor, NJ

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