FDAAugust 31, 2023device
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
What to do
FDA enforcement status: Ongoing
Brands named
access vascularaccess
UPCs
00850030354068
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAArtegraft Vascular Graft; REF#: AG740;2026-02-10
- FDABroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 600602025-12-12
- FDASafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,2025-11-06
- FDAArtegraft¿ Collagen Vascular Graft; REF: AG1015;2025-09-25
- FDAArtegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;2025-09-02
- FDAArtegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.2025-08-25
- FDAVenclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically ...2025-08-21
- FDABrand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes ...2025-05-16
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →