FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies: Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
- Recall number
- Z-1236-03
- Recalling firm
- GE Medical Systems Information Technologies
- Product
- Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
- Status
- Terminated
- Initiated
- 2000-10-24
- Posted
- 2003-09-17
- Terminated
- 2008-06-06
- Reason
- Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
- 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
- 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.
- Lot, serial or model codes
- lot number 2290
- 510(k) numbers
- ["K974080"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1030184
- Firm city
- Tampa
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28