FDA recall Z-1777-2022

Product

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.

Distribution

US distribution to distributors in IL, IN, MI, NC, OH, and TX

Key facts

Status

Ongoing

Initiation date

2022-08-03

Report date

2022-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oakland, NJ, United States

Primary source

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