Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
This recall has been terminated (originally issued September 17, 2003).
- Recall Initiated
- October 24, 2000
- Posted
- September 17, 2003
- Terminated
- June 6, 2008
- Recall Number
- Z-1236-03
- Quantity
- 235
- Firm Location
- Tampa, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
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 / Code Info
lot number 2290
Root Cause
Other
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.