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Recall Observatory FDA recall evidence

Device product

Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

Z-2495-2021

August 09, 2021

Class II

Product summary

Firm
Ad-Tech Medical Instrument Corporation
Event
Event 88590
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2495-2021

Official wording

Reason: Incorrect version of labels were used.

Code information: Item Code & Lot #: L-DCL-6DIN Lot # 121260; L-DCL-10DIN Lot #'s 124060 and 120340; L-DCL-16BDIN Lot # 120240.

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of DC, FL, MI, NY, PA and TX and the countries of Spain, France, Italy, Greece, Great Britain and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect version of labels were used.