PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 5, 2022 Initiated: August 3, 2022 #Z-1777-2022

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Collagen Matrix Inc
Units Affected
1336 units
Distribution
US distribution to distributors in IL, IN, MI, NC, OH, and TX
Location
Oakland, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Collagen Matrix Inc. Units affected: 1336 units.
Why was this product recalled?
The packaging may not be sealed, which could compromise sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1777-2022.