Collagen Matrix Inc: 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, 25

Is my product affected?

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

• UPC 00366975012616
• UPC 10366975012613
• UPC 00813954023571
• UPC 10813954023578
• UPC 00813954022079
• UPC 10813954022076
• UPC 00842517100084
• UPC 00842517100077

Check against the official notice below — it lists the full affected range.

What happened

Collagen Matrix Inc. is recalling 1,336 units of collagen dental wound dressing products sold under multiple brand names including Cytoplast RTMTAPE, GIBSON Healthcare, MaxxTape, NEOTAPE, and Karl Schumacher Dental. The products are bovine dermis tape measuring 25mm x 75mm that were distributed to distributors in Illinois, Indiana, Michigan, North Carolina, Ohio, and Texas. The recall was issued because the packaging may not be sealed properly, which could compromise the sterility of the product.

The affected products include specific lot numbers and UDI codes listed in the recall notice, with the primary lots being E1C0070A (Cytoplast RTMTAPE) and BDDWTU211002 (GIBSON Healthcare, MaxxTape, NEOTAPE, and Karl Schumacher Dental). The source record does not specify a remedy or instructions for consumers regarding what action they should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Quantity: 1336 units Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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