PriMatrix Ag recall: Endotoxin
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Why was PriMatrix Ag recalled?
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item No. (UDI-DI): 607-101-112 (10381780113492), 607-101-125 (10381780113508), 607-101-225 (10381780113515), 607-101-440 (10381780113522), 607-101-660 (10381780113539), 607-101-812 (10381780113546), 607-101-880 (10381780113553).
- Product
- PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
- Recalling firm
- TEI Biosciences, Inc.
- Quantity
- 1,689 units
- Distribution
- Domestic: Nationwide Distribution.
- Recall date
- July 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)