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Recall Observatory FDA recall evidence

Device product

HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

Z-1129-2023

December 16, 2022

Class II

Product summary

Firm
Access Vascular, Inc
Event
Event 91426
Status
Ongoing
Classification
Class II
Quantity
1,789 HydroMID devices
Official record key
device-enforcement:Z-1129-2023

Official wording

Reason: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

Code information: UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226

Distribution pattern: US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.