Patterson Procedure Earloop Masks Recalled Due to Non-Validated Production Equipment
Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.
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 medical device recall. The defect involves non-validated production equipment, a manufacturing quality issue. The recall contains no reports of illnesses, injuries, or harm. Per the severity rubric, Class II recalls without reported hospitalization or significant injury are classified as High (3) severity.
Plain-English summary
AMD Medicom Inc. is recalling Patterson Procedure Earloop Masks - Anti-Fog, ASTM Level 3 (blue), item code 127-7573. The recall affects 180 cases distributed nationwide in Florida, Iowa, Indiana, Pennsylvania, Nevada, and Texas. Affected lot numbers are 2339 and 2342 (UDI DI: D6620712775732).
The manufacturing issue stems from the use of alternate production equipment that was not included in the initial product qualification process. This means the production equipment had not undergone validation to ensure proper operation and product quality.
The recalled product
- Product
- PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
- Manufacturer
- AMD Medicom Inc.
- Category
- Medical Device — Procedure Masks
- Hazard
- manufacturing-defect
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 (4)
- Item Code: 127-7573
- UDI DI: D6620712775732
- Lot #s: 2339
- 2342
Distribution
Distributed nationwide across the United States.
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