HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Reported: October 25, 2023 Initiated: August 31, 2023 #Z-0115-2024
Product Description
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Reason for Recall
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.
Details
- Recalling Firm
- Access Vascular, Inc
- Units Affected
- 58 total
- Distribution
- US Nationwide distribution in the states of IL, TX.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004. Recalled by Access Vascular, Inc. Units affected: 58 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2023. Severity: Moderate. Recall number: Z-0115-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11