TEI Biosciences, Inc. 2023-07-12 Health serious FDA
Health · FDA · Recall #FDA-Z-2082-2023
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm… Recall
Issued July 12, 2023 · TEI Biosciences, Inc.
In July 2023, TEI Biosciences, Inc. recalled the PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
What you should do
- 1 Stop using PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact TEI Biosciences, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- TEI Biosciences, Inc.
- Category
- Health
- Recall date
- July 12, 2023
- Units affected
- Not reported
- Sold at
- Domestic: Nationwide Distribution.
- Recall number
- FDA-Z-2082-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- TEI Biosciences, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.