Henry Schein Criterion Anti-Fog Earloop Masks Recalled for Equipment Validation Issue
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of medical protective equipment where the manufacturing process was not validated according to product qualification standards. No illnesses or injuries have been reported, but manufacturing controls are critical for ensuring the safety and performance of protective equipment.
Plain-English summary
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue), item code 570-3281. The recall affects 960 cases (containing 10 boxes per case and 50 masks per box) distributed nationwide in Florida, Iowa, Indiana, Pennsylvania, Nevada, and Texas.
The masks were manufactured on alternate production equipment that was not included as part of the initial product qualification process. This represents a manufacturing control issue that may affect product quality and performance.
Consumers who have purchased these masks should discontinue use and contact their supplier or AMD Medicom Inc. for instructions on how to obtain replacement products. The recalled lot numbers are 2340, 2341, and 2342, and the UDI Device Identifier is 10304040168629.
The recalled product
- Product
- HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
- Manufacturer
- AMD Medicom Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Item Code: 570-3281
- UDI DI: 10304040168629
- Lot #s: 2340
- 2341
- 2342
Distribution
Part of a larger recall action
This product is one of 3 recalled by AMD Medicom Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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