Device product
MAMMOGRAPHY
Z-2592-2016
Product summary
- Event
- Event 73465
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200
- Official record key
device-enforcement:Z-2592-2016
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. LGHM022-02 , LOT# 1021706
Distribution pattern: Recalled product was distributed to 2 states: Virginia and Massachusetts.
Derived failure modes
-
Unknown
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.