FDA Device

Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 0.5mm I.D., REF 21-1501-01

Hazard

Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

What You Should Do

Remedy

A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.

Products

Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 0.5mm I.D., REF 21-1501-01
Brand
Deltec, Inc
UPC
Lot M27052