FDADecember 21, 2023device
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
What to do
FDA enforcement status: Ongoing
Brands named
amd medicomamd
UPCs
10304040142520
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARitmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C2026-05-08
- FDARitmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C2026-05-08
- FDAPATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)2023-12-21
- FDAHENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)2023-12-21
- FDAMEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 20402019-10-11
- FDAMEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 20422019-10-11
- FDAAMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 141502016-06-08
- FDAAMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- T...2016-03-30
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