Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
FDA device recall Z-1236-03 · posted 2003-09-17 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Technologies
- Reason for recall
- Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 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.
- Date initiated
- 2000-10-24
- Date posted
- 2003-09-17
- Date terminated
- 2008-06-06
- Location
- Tampa, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRITIKON SOFT BLOOD PRESSURE CUFF (K974080) | Johnson & Johnson Medical, Inc. | 1998-05-18 |