Z-1236-03

Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure...

Name: Z-1236-03 Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure...
Creator: GE Medical Systems Information Technologies
Published: 2000-10-24
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2000-10-24 / Terminated

FDA source

GE Medical Systems Information Technologies began a recall of Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor on 2000-10-24. The reason FDA records is "Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1236-03
Status: Terminated
Initiated: 2000-10-24
Posted: 2003-09-17
Terminated: 2008-06-06
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
Reason for recall: Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
FDA root cause: Other
Action: A Recall notification letter was mailed to all direct accounts on 10/24/2000 followed by a telephone call to each direct account. Distributors were not requested to subrecall because Critikon already knew the hospital accounts that had recieved product and they were notified via the 10/24/00 letter and phone call. Accounts were told to return product to Critikon for replacement.
Quantity in commerce: 235
Distribution: Product was distributed to the firm''s related warehouse in Texas and then on to 20 distributors and 8 hospitals in the United States and also one international distributor in Japan.
Product codes and lots: lot number 2290

K974080Class IICritikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. / cleared 1998-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)