The FDA announced on 2017-11-22 that Medical Components, Inc dba MedComp voluntarily recalled 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter kits due to packaging errors. The hazard involves incorrect guidewires being included in the kits.
How to tell if you have it
- Brand: MedComp
- Product: 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
- Catalog #: MRDP80PLN
- Lot #: MJKK420
- Exp. Date: 2022-01-09
- UDI#: 884908110449
- Distribution: CA, AR, AL
The hazard
The kits were packaged with an unmarked guidewire instead of the marked guidewire indicated on the label. This discrepancy constitutes the primary hazard identified in the recall record.
Context
GovInfoNow's records show Medical Components, Inc dba MedComp has 7 other recalls on record since 2018-02-23. Other recent recalls of similar products include Medline Medical Procedure Kits Recall: Catheter Issues (2026-05-04), Medline Namic Guidewires Recall: 510(k) Clearances Rescinded (2026-02-25), and Terumo Glidesheath Slender A-Kit 6F 10CM: Wrong Guidewire Risk (2026-06-15).