AMD Medicom Inc. recalls anti-fog earloop masks (item code 127-757: blue, ASTM Level 3) made on unvalidated equipment. These masks may not meet safety standards.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
AMD Medicom Inc. is recalling Patterson Procedure anti-fog earloop masks (blue, ASTM Level 3) because they were made on unvalidated production equipment. This could mean the masks don't meet safety standards.
The masks were produced on alternate non-validated equipment that wasn't included in the initial product qualification. This means they might not meet the required safety standards for ASTM Level 3 masks.
Patterson Procedure earloop masks with item code 127-7573 (blue, ASTM Level 3) were sold in specific lots. Users of these masks may be affected.
Check for item code 127-7573 on the mask packaging. The masks are blue and meet ASTM Level 3 standards. They were sold in lots 2339 and 2342.
Look for item code 127-7573 on the mask packaging to confirm if it's part of the recall.
The recall states these masks were made on unvalidated equipment, so they may not meet safety standards. AMD Medicom Inc. has not provided a specific remedy.
The recall does not specify a remedy, so there is no action required beyond checking if you have the item code 127-7573.
Check for item code 127-7573 on the mask packaging. The masks are blue and meet ASTM Level 3 standards, sold in lots 2339 and 2342.
We’ve drafted a message you can send PATTERSON PROCEDURE to request your refund or repair — edit it as you like.
Subject: Recall Z-1148-2024 — PATTERSON PROCEDURE PATTERSON PROCEDURE Hello, I own a PATTERSON PROCEDURE that is covered by recall Z-1148-2024 from PATTERSON PROCEDURE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
