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Recall Observatory FDA recall evidence

Device product

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

Z-0698-2021

November 10, 2020

Class III

Product summary

Firm
Applied Medical Technology Inc
Event
Event 86828
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
device-enforcement:Z-0698-2021

Official wording

Reason: The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

Code information: Box Lot Number 200918-103; Pouch Lot Number 200902-075

Distribution pattern: US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.