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.
| Date | Sep 17, 2003 (initiated Oct 24, 2000) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974080 | CRITIKON SOFT BLOOD PRESSURE CUFF Johnson & Johnson Medical, Inc., May 18, 1998 |