Recall Z-1777-2022— Collagen Matrix Inc
Class II · Ongoing
Class II FDA medical device recall by Collagen Matrix Inc, initiated 2022-08-03. It names one FDA 510(k) clearance: K152600. 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: The packaging may not be sealed, which could compromise sterility..
- Recalling firm
- Collagen Matrix Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-03
- Firm location
- Oakland, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.