9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition
Check against the official notice below — it lists the full affected range.
Medical Components, Inc. is recalling 9.6F Plastic Dignity Mid-Sized CT Ports with Pre-Attached Silicone Catheters used for patient infusion therapies. The problem is that the kits were packaged with a 9F valved peelable introducer, even though the label indicates the kit contains a 10F valved peelable introducer. Because of this mismatch, the port lumen will not fit through the introducer during the insertion procedure.
The recall affects 71 units worldwide, distributed to Puerto Rico and Panama. The affected lot is MRCTI96801 Lot# MHWQ060 S2, with UDI# 884908031232. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
Reason for recall: The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure. Distribution: Worldwide Distribution to PR and Panama Quantity: 71 units Lot/code info: MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.