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Recall Observatory FDA recall evidence

Device product

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

Z-2496-2021

August 09, 2021

Class II

Product summary

Firm
Ad-Tech Medical Instrument Corporation
Event
Event 88590
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-2496-2021

Official wording

Reason: Incorrect version of labels were used.

Code information: Item Code & Lot #: L-DC-10DIN Lot #'s 121240 and 126270.

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.