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Terminated

MAMMOGRAPHY

FDA Recall Z-2592-2016 · Posted 2016-08-18

Recalling FirmAvid Medical, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2015-10-05
Date Terminated2017-01-10
Product Quantity200

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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