—#144246

Product

MAMMOGRAPHY

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog No. LGHM022-02 , LOT# 1021706

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Avid Medical, Inc.
Address: 9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

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

Timeline

Recall initiated: 2015-10-05
Posted by FDA: 2016-08-18
Terminated: 2017-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.