ProgenaCare recalls sterile keratin matrix products with model numbers PM2012, PM3002, PM3004, PM3006, and PM3010 due to potential lack of sterility from inadequate inner pouch seals.
Inner pouch seal may be inadequate resulting in lack of sterility.
ProgenaCare is recalling sterile human keratin matrix products that may not be properly sterile because the inner pouch seal could be inadequate. This could lead to infection if used without proper sterility.
The inner pouch seal might not seal properly, which could allow contamination and reduce the product's sterility. This poses a risk of infection if the product is used without being sterile.
Patients using ProgenaCare's sterile keratin matrix products for medical treatment are affected. Those with the specific model numbers and lots listed in the recall are most at risk.
Check for model numbers PM2012, PM3002, PM3004, PM3006, or PM3010 with specific lot numbers and expiration dates listed in the recall notice.
Identify the model number and lot number on the product to see if it matches the recalled items listed in the notice.
The inner pouch seal may be inadequate, resulting in a lack of sterility, which could lead to infection if used without proper sterility.
Model numbers PM2012, PM3002, PM3004, PM3006, and PM3010 with specific lot numbers and expiration dates listed in the recall notice.
The recall does not specify a stop-use instruction; you should check if your product matches the recalled model numbers and lots.
We’ve drafted a message you can send ProgenaCare to request your refund or repair — edit it as you like.
Subject: Recall Z-1137-2022 — ProgenaCare ProgenaCare Hello, I own a ProgenaCare that is covered by recall Z-1137-2022 from ProgenaCare. 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.