FDA-Device2022-10-05Class II

Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm

Collagen Matrix Inc
Hazard

The packaging may not be sealed, which could compromise sterility.

Sold states
US distribution to distributors in IL, IN, MI, NC, OH, and TX
Affected count
1336 units
Manufactured in
15 Thornton Rd, N/A, Oakland, NJ, United States
Products
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1777-2022

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