FDAClass IIFebruary 28, 2024

Patterson¿ Procedure Earloop Masks- Anti-fog recall

PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)

Why was Patterson¿ Procedure Earloop Masks- Anti-fog recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Code: 127-7573; UDI DI: D6620712775732; Lot #s: 2339, 2342;

Product
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Recalling firm
AMD Medicom Inc.
Quantity
180 cases (10 boxes/case and 50 masks/box)
Distribution
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Recall date
February 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls