FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: 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 number
- Z-1626-2012
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-04-12
- Posted
- 2012-05-18
- Terminated
- 2013-07-18
- Reason
- 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
- Root cause
- Employee error
- 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.
- Quantity
- 50 trays
- Distribution
- Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.
- Lot, serial or model codes
- Lot #MDPZ600 Expiration date 2015/02
- 510(k) numbers
- ["K070003"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 2518902
- Firm city
- Harleysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28