Atlas FDA

Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

FDA device recall Z-2589-2016 · posted 2016-08-18 · Terminated

Recall details

Recalling firm
Avid Medical, Inc.
Reason for recall
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.
Action taken
Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 cm) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Root cause
Employee error
Status
Terminated
Product code
LRO
Quantity affected
240
Distribution
Recalled product was distributed to 2 states: Virginia and Massachusetts.
Date initiated
2015-10-05
Date posted
2016-08-18
Date terminated
2017-01-10
Location
Toano, VA

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