FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
- Recall number
- Z-1271-2018
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
- Status
- Terminated
- Initiated
- 2017-11-22
- Posted
- not on file
- Terminated
- 2018-07-11
- Reason
- The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
- Root cause
- Mixed-up of materials/components
- Action
- Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/
- Quantity
- 24 Eaches
- Distribution
- CA, AR. AL
- Lot, serial or model codes
- Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449
- 510(k) numbers
- ["K132177"]
- 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