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 Initiated
- April 12, 2012
- Posted
- May 18, 2012
- Terminated
- July 18, 2013
- Recall Number
- Z-1626-2012
- Quantity
- 50 trays
- Firm Location
- Harleysville, PA
Reason for Recall
50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
Distribution
Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.
Lot / Code Info
Lot #MDPZ600 Expiration date 2015/02
Root Cause
Employee error
Action Taken
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.
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