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i-STAT G3+ Cartridge recallZ-1541-2009 · Abbott Point of Care Inc. · initiated Feb 23, 2009

Terminated All recalls posted in June 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Point of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1541-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 23, 2009
Posted by the FDA
Jun 18, 2009
Recalling firm
Abbott Point of Care Inc.
Quantity
1136 boxes of 25 cartridges each
Product code
CHL
FDA submissions
K940918
Distribution
Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.

Product description

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.

Code information (models, lots, serial numbers)

Lot P08321C, Abbott List number 06F03-01 (USA and Canada), Abbott List Number (rest of world) 06F03-02; Box numbers 1491 and 1534.

Other devices under the same FDA submission

5 devices cleared under K940918 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 51211).

Sources and updates

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