FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
- Recall number
- Z-2235-2010
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
- Status
- Terminated
- Initiated
- 2010-07-02
- Posted
- 2010-08-17
- Terminated
- 2010-10-13
- Reason
- Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
- Root cause
- Employee error
- Action
- Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.
- Quantity
- 47 units
- Distribution
- Worldwide Distribution -- USA, including states of NC and TX and country of Israel.
- Lot, serial or model codes
- Lot #MAZL630, Exp. 04/2015
- 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