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Recall Observatory FDA recall evidence

Device product

HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

Z-1130-2023

December 16, 2022

Class II

Product summary

Firm
Access Vascular, Inc
Event
Event 91426
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1130-2023

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)00862559000463; Lot Number: 11389279, 11391525

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.