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Recall Observatory FDA recall evidence

Device product

HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002

Z-0114-2024

August 31, 2023

Class II

Product summary

Firm
Access Vascular, Inc
Event
Event 93043
Status
Ongoing
Classification
Class II
Quantity
58 total
Official record key
device-enforcement:Z-0114-2024

Official wording

Reason: 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.

Code information: UDI-DI: 00850030354044; Lot Number: 11423187

Distribution pattern: US Nationwide distribution in the states of IL, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.