AMD Medicom Level 2 Masks Recalled Due to Packaging Error
AMD Medicom Inc. is recalling Level 2 masks that may have been packed in Level 3 boxes, creating a risk of using lower-protection masks.
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: The recall involves a risk-of-harm product where the hazard is using a mask with lower protection than intended, but no injuries or illnesses have been reported.
Plain-English summary
AMD Medicom Inc. is recalling MEDICOM SAFEMASK PREMIER PLUS ASTM Level 2 Masks, Item Code 2040, Lot 1917. The recall involves 756 cases (500 units per case) of the product.
The recall was initiated due to an error on the packaging line where some Level 2 masks may have been packed in Level 3 mask boxes. Because the two masks are visually indistinguishable, there is a risk that users may utilize a mask with a lower protection level than intended.
The affected products were distributed to the following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were also distributed to Canada. Consumers should stop using the affected masks and contact the recalling firm for instructions.
The recalled product
- Product
- MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
- 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 (1)
- Lot 1917
Distribution
Part of a larger recall action
This product is one of 2 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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