Recall Z-2592-2016 ยท LRO General Surgery Tray
Avid Medical, Inc.
MAMMOGRAPHY
| Date | Aug 18, 2016 (initiated Oct 5, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| 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. |
| Quantity | 200 |
| Distribution | Recalled product was distributed to 2 states: Virginia and Massachusetts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.