FDA Recall
Terminated
8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.
Recall: Z-1626-2012
·
Initiated April 12, 2012
Recall
- Recall Number
- Z-1626-2012
- Event Number
- 61860
- Firm
- Medical Components, Inc dba MedComp
- FEI Number
- 2518902
- Product Code
- LJT
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- April 12, 2012
- Posted
- May 18, 2012
- Terminated
- July 18, 2013
- Address
- 1499 Delp Dr, Harleysville, PA, 19438
Description
8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.
Reason
50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
Action
On April 12, 2012, MedComp sales representatives and the foreign distributor were notified via e-mail with a "Product Alert" notification. The issue was described and requested actions were provided to recipients.
Distribution
Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.
Quantity
50 trays