Collagen Matrix Inc Recall 90783
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
Collagen Matrix Inc Recall 90783 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1777-2022 |
| Event ID | 90783 |
| Event 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 |
| Product Type | Devices |
| Distribution | US distribution to distributors in IL, IN, MI, NC, OH, and TX |
| Quantity | 1336 units |
| Recall Reason | The packaging may not be sealed, which could compromise sterility. |
| Device Classification | 20221005 |
| Device Code Info | 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 |
| Center Classification Date | 20220923 |
| Recall Initiation Date | 20220803 |
| Recalling Firm | Collagen Matrix Inc |
| Initial Notification | Letter |
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