Z-1146-2024Class II

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

Name: Z-1146-2024 HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Creator: AMD Medicom Inc.
Published: 2023-12-21
License: https://open.fda.gov/license/

AMD Medicom Inc. / initiated 2023-12-21 / Open, Classified / root cause: manufacturing process

FDA source

AMD Medicom Inc. began a recall of HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) on 2023-12-21. FDA classified it as Class II and gives the reason as "Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1146-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-02-16
Recalling firm: AMD Medicom Inc.
Product: HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Product code: FXX Mask, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 12/21/2023 were sent to customers. AMD Medicom requests that you discontinue distribution/use of and return all products from the catalog/lot number referenced above, for a credit. Our records indicate that you have purchased one or more of the referenced products for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. AMD Medicom requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the above-mentioned lot numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base, advise them of the recall and provide them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgement Form and request that they return the Acknowledgment Form to you. Please have them return any unused inventory to you for reconciliation. Once you have received all inventory from your customers, please contact Medicom customer service at 1-800-308-6589 or [email protected] to receive a Sales Return Order number to identify your shipment of returns. Please return all units of the affected lots (unsold inventory and returns) to: AMD Medicom Inc. 6054 Shook Road, Suite 200 Lockbourne, OH USA 43137 ATTN: Recall. You may use the following courier information: UPS Account# 1149-6837-4.
Quantity in commerce: 720 cases (10 boxes/case and 50 masks/box)
Distribution: US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Product codes and lots: Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1147-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1148-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code FXX

K051291Class IINon-Sterile Surgical MaskA.R. Medicom, Inc. / cleared 2005-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)