Dignity Low Profile CT Port recallZ-1271-2018 · Medical Components, Inc dba MedComp · initiated Nov 22, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Components, Inc dba MedComp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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/
Recall details
- Recall number
- Z-1271-2018
- Status
- Terminated
- Initiated by the company
- Nov 22, 2017
- Recalling firm
- Medical Components, Inc dba MedComp
- Quantity
- 24 Eaches
- Product code
- LJT
- FDA submissions
- K132177
- Distribution
- CA, AR. AL
Product description
8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
Code information (models, lots, serial numbers)
Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dignity® Low Profile CT Port MRDP80PLNMedical Components, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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