AMD Medicom Inc.: Level 3 Face Masks Recalled Due to Non-Validated Production Equipment

Agency Publication Date: February 16, 2024

Summary

Approximately 1,860 units of Henry Schein Criterion and Patterson Procedure Level 3 earloop masks are being recalled because they were manufactured using alternate production equipment that was not properly validated or qualified. This lack of validation means the company cannot guarantee the masks meet the necessary safety and performance standards for surgical or medical environments. Affected models include standard and anti-fog blue Level 3 masks sold in cases of 10 boxes. Consumers should check their supply for the specific lot numbers and item codes involved in this voluntary recall.

Risk

Using medical masks produced on unvalidated equipment may mean the masks do not provide the expected level of fluid resistance or filtration. This could potentially expose healthcare providers or patients to infectious materials or fluids during medical procedures.

What You Should Do

Identify if you have the affected masks by checking the 'Item Code' and 'Lot #' on the product packaging. For Henry Schein Criterion Blue Level 3 masks (Item 570-2448), check for lot numbers 2337, 2338, 2342, 2343, and 2344.
Check Henry Schein Criterion Anti-Fog Blue Level 3 masks (Item 570-3281) for lot numbers 2340, 2341, and 2342.
Check Patterson Procedure Anti-Fog Blue Level 3 masks (Item 127-7573) for lot numbers 2339 and 2342.
Locate the UDI DI numbers on the packaging to confirm the recall: 10304040142520 (Criterion Blue), 10304040168629 (Criterion Anti-Fog), or D6620712775732 (Patterson Anti-Fog).
Stop using these specific masks immediately and contact your healthcare provider or AMD Medicom Inc. for further instructions regarding the return or replacement of these products.
Contact AMD Medicom Inc. at their Montreal headquarters or through your distributor (Henry Schein or Patterson Dental) to arrange for a potential refund or replacement.
For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE)

Model / REF:

570-2448

UDI DI: 10304040142520

Lot Numbers:

2337

2338

2342

2343

2344

Product: HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE)

Model / REF:

570-3281

UDI DI: 10304040168629

Lot Numbers:

2340

2341

2342

Product: PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE)

Model / REF:

127-7573

UDI DI: D6620712775732

Lot Numbers:

2339

2342

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93818

Status: Active

Manufacturer: AMD Medicom Inc.

Sold By: Henry Schein; Patterson Dental

Manufactured In: Canada

Units Affected: 3 products (720 cases (10 boxes/case and 50 masks/box); 960 cases (10 boxes/case and 50 masks/box); 180 cases (10 boxes/case and 50 masks/box))

Distributed To: Florida, Iowa, Indiana, Pennsylvania, Nevada, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected masks by checking the 'Item Code' and 'Lot #' on the product packaging. For Henry Schein Criterion Blue Level 3 masks (Item 570-2448), check for lot numbers 2337, 2338, 2342, 2343, and 2344.

Check Henry Schein Criterion Anti-Fog Blue Level 3 masks (Item 570-3281) for lot numbers 2340, 2341, and 2342.

Check Patterson Procedure Anti-Fog Blue Level 3 masks (Item 127-7573) for lot numbers 2339 and 2342.

Locate the UDI DI numbers on the packaging to confirm the recall: 10304040142520 (Criterion Blue), 10304040168629 (Criterion Anti-Fog), or D6620712775732 (Patterson Anti-Fog).

Stop using these specific masks immediately and contact your healthcare provider or AMD Medicom Inc. for further instructions regarding the return or replacement of these products.

Contact AMD Medicom Inc. at their Montreal headquarters or through your distributor (Henry Schein or Patterson Dental) to arrange for a potential refund or replacement.

For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE)

Model / REF:

570-2448

UDI DI: 10304040142520

Lot Numbers:

2337

2338

2342

2343

2344

Product: HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE)

Model / REF:

570-3281

UDI DI: 10304040168629

Lot Numbers:

2340

2341

2342

Product: PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE)

Model / REF:

127-7573

UDI DI: D6620712775732

Lot Numbers:

2339

2342

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93818

Status: Active

Manufacturer: AMD Medicom Inc.

Sold By: Henry Schein; Patterson Dental

Manufactured In: Canada

Units Affected: 3 products (720 cases (10 boxes/case and 50 masks/box); 960 cases (10 boxes/case and 50 masks/box); 180 cases (10 boxes/case and 50 masks/box))

Distributed To: Florida, Iowa, Indiana, Pennsylvania, Nevada, Texas