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L-Cath PICC 384466

by Argon Medical Devices, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886333209859 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2804-2026 FDA Class II initiated 15 Jun 2026
    • Ongoing Z-2803-2026 FDA Class II initiated 15 Jun 2026

    Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.

    • Ongoing Z-2638-2024 FDA Class II initiated 14 Jun 2024

    Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
L-Cath PICC
Generic Name
Peripherally-inserted central venous catheter
Model / Ref / Catalog
384466
Primary DI / UDI-DI
00886333209859
510(k) Number
FDA Product Code
LJS, FOZ
GMDN Term
Peripherally-inserted central venous catheter
Device Class
Class II
Regulation Number
880.5970, 880.5200
GUDID distribution status
In Commercial Distribution

Other devices from Argon Medical Devices, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No