TEI Biosciences recalls PriMatrix Ag Dermal Repair Scaffolds (Rx Only) due to possible endotoxin test failures. Affected sizes include 4x4 cm to 20x25 cm. No remedy specified in recall notice.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling PriMatrix Ag Dermal Repair Scaffolds (Rx Only) because endotoxin testing may have been inaccurate. This could potentially lead to unsafe levels of endotoxins in the product, though the recall does not specify a remedy.
The recall states that endotoxin test results may be out of specification due to issues with testing in-process and finished goods. Endotoxins are bacterial components that can cause serious infections if introduced into the body during medical procedures.
Medical professionals who use these scaffolds for skin repair procedures are likely affected. Patients using these products under medical supervision may also be at risk if the endotoxin levels are unsafe.
Check for the product names 'PriMatrix Ag; Dermal Repair Scaffold; Rx Only' with sizes ranging from 4x4 cm to 20x25 cm. The unique identifiers include item numbers like 607-101-112 (10381780113492) through 607-101-880 (10381780113553).
Review the product name, sizes, and unique identifiers listed in the recall notice to confirm if your item is affected.
The recall notice does not specify any remedy.
The recall states that endotoxin test results may be out of specification, which could lead to unsafe levels of endotoxins in the product.
Sizes 4x4 cm, 6x6 cm, 8x8 cm, 8x12 cm, 10x12 cm, 10x25 cm, and 20x25 cm are affected.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2080-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2080-2023 from TEI Biosciences. 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.
