Henry Schein Criterion Level 3 Earloop Masks Recalled for Non-Validated Equipment
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This FDA Class II recall addresses masks produced on non-validated equipment. Per the rubric criteria for Score 3, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.
Plain-English summary
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks (item code 570-2448) distributed nationwide. The masks were produced on alternate production equipment that was not validated and was not included in the initial product qualification process.
Affected lot numbers are 2337, 2338, 2342, 2343, and 2344. The recall involves 720 cases distributed in Florida, Iowa, Indiana, Pennsylvania, Nevada, and Texas.
Because these masks were produced on non-validated equipment, there is concern that they may not meet their intended specifications or performance standards.
Consumers and healthcare facilities should stop using masks from the affected lot numbers and contact AMD Medicom Inc. or their distributor for information regarding replacement or return.
The recalled product
- Product
- HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
- 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 (7)
- Item Code: 570-2448
- UDI DI: 10304040142520
- Lot #s: 2337
- 2338
- 2342
- 2343
- 2344
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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