Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0467-06

BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap...

Becton Dickinson & Co / initiated 2005-11-17 / Terminated

Becton Dickinson & Company began a recall of BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is... on . The reason FDA records is "The catheter connector could not be sufficiently tightened to secure the catheter tubing". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0467-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.
Product code
GCD Connector, Catheter
Reason for recall
The catheter connector could not be sufficiently tightened to secure the catheter tubing.
FDA root cause
Other
Action
Recall letters were sent to all direct consignees and potential end users of the product on 11/17/2005. Letters were mailed via UPS second day air.
Quantity in commerce
1410 units
Distribution
The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.
Product codes and lots
Reorder Number 400507 Lot Number 5222801.