Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0090-06

Premicath 28G PICC Catheter

Vygon U.S.A. / initiated 2005-06-27 / Terminated

Vygon Corporation began a recall of Premicath 28G PICC Catheter on . The reason FDA records is "Guidewire protuding from tip of the catheter". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0090-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Vygon U.S.A.
Product
Premicath 28G PICC Catheter
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall
Guidewire protuding from tip of the catheter
FDA root cause
Other
Action
The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.
Quantity in commerce
243 units
Distribution
The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.
Product codes and lots
Lot numbers 014434 and 012615