Recall Z-1146-2024— AMD Medicom Inc.

Name: FDA recall Z-1146-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Class II · Ongoing

Class II FDA medical device recall by AMD Medicom Inc., initiated 2023-12-21. It names one FDA 510(k) clearance: K051291. Product: HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448). Reason: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products..

Recalling firm: AMD Medicom Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-21
Firm location: Montreal, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K051291 — NON-STERILE SURGICAL MASKA.R. Medicom, Inc.·cleared 2005-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

Reason for recall

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

Data sourced from openFDA. This site is unofficial and independent of the FDA.