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Recall Observatory FDA recall evidence

Device product

Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

Z-2589-2016

October 05, 2015

Class II

Product summary

Firm
Avid Medical, Inc.
Event
Event 73465
Status
Terminated
Classification
Class II
Quantity
240
Official record key
device-enforcement:Z-2589-2016

Official wording

Reason: Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.

Code information: Catalog No. MCVA0089-04 , LOT# 1010997

Distribution pattern: Recalled product was distributed to 2 states: Virginia and Massachusetts.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.