ODYClass II

Tunneled Catheter Remover

General Hospital · 21 CFR 880.5970

To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.

MDR events1All time

Recalls1All time

Registered firms9Currently listed

510(k) clearances2All time

Recent MDR events

1 adverse event reports on file

TDC PA CATHETERNov 18, 2010
MalfunctionIcu Medical, Inc.2025816-2010-00089

Event type breakdown

Malfunction1

Most-reported manufacturers

Icu Medical, Inc.1

Recalls

1 recall events for this product code

Merit Medical Systems, Inc.
Open, ClassifiedAug 12, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2559-2024 · View FDA record ↗

Registered firms

9 firms currently registered for this product code

510(k) clearances

2 clearances for this product code