Official recall record
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-08-31
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00850030354068
- Brand on record
- Access Vascular, Inc
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-08-31 · US FDA — Medical Devices
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
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