FDA-Device2023-07-12Class II
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
TEI Biosciences, Inc.
Hazard
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Sold states
Domestic: Nationwide Distribution.
Affected count
1,689 units
Manufactured in
7 Elkins St, N/A, Boston, MA, United States
Products
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2080-2023Don't want to check this manually?
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