Z-1777-2022 Class II Ongoing
FDA device recall Z-1777-2022 was initiated by Collagen Matrix Inc on August 3, 2022 and is designated Class II. Reason for recall: The packaging may not be sealed, which could compromise sterility. The recall status is ongoing. Affected quantity: 1336 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- August 3, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1336 units
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.
Distribution Pattern
US distribution to distributors in IL, IN, MI, NC, OH, and TX
Code Information
1) UDI (1 unit package): +D765RTMTAPE100/$$3250131E1C0070AJ; (10 units package): +D765RTMTAPE101/$$3250131E1C0080AK Cytoplast RTMTAPE, Lot E1C0070A 2) UDI (1 unit package): (01)00366975012616(17)250131(10)BDDWTU211002; (10 units package): (01)10366975012613(17)250131(10)BDDWTU211002 GIBSON Healthcare, REF 5251-194; Lot BDDWTU211002 3) UDI (1 unit package): (01)00813954023571(17)250131(10)BDDWTU211002; (10 units package): (01)10813954023578(17)250131(10)BDDWTU211002 MaxxTape, Ref: XTAPE; Lot BDDWTU211002 4) UDI (1 unit package): (01)00813954022079(17)250131(10)BDDWTU211002; (5 units package): (01)10813954022076(17)250131(10)BDDWTU211002 NEOTAPE, Lot BDDWTU211002 5) UDI (1 unit package): (01)00842517100084(17)250131(10)BDDWTU211002; (10 units package): (01)00842517100077(17)250131(10)BDDWTU211002 Karl Schumacher Dental, REF RCWT0001; Lot BDDWTU211002