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Recall Observatory FDA recall evidence

Device product

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

Z-2494-2021

August 09, 2021

Class II

Product summary

Firm
Ad-Tech Medical Instrument Corporation
Event
Event 88590
Status
Terminated
Classification
Class II
Quantity
69
Official record key
device-enforcement:Z-2494-2021

Official wording

Reason: Incorrect version of labels were used.

Code information: Item Code & Lot #: L-SRL-10DIN Lot #'s 120340, 122140 and 124140; L-SRL-10DIN-84 Lot #'s 126270 and 127270; L-SRL-12BDIN Lot # 125250; L-SRL-16BDINLot #124150; L-SRL-20DINLot # 127060; L-SRL-32BDIN Lot # 126070 L-SRL-4DIN Lot #'s 123050, 129150 and 120250; L-SRL-64BDIN Lot #127270; L-SRL-6DINLot #'s 128060 and 120160; L-SRL-8DIN Lot #'s 128150 and 124050; L-SRL-8DIN-11 Lot # 125170

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.