Collagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise
Collagen Matrix Inc is recalling Collagen Dental Wound Dressing products because packaging may not be sealed, potentially compromising sterility. Affected products were distributed to medical distributors in six states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device where packaging defect risks compromised sterility and potential infection. No reported illnesses or injuries, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Collagen Matrix Inc is recalling Collagen Dental Wound Dressing - Bovine Dermis Tap (25mm x 75mm) sold under multiple brand names including Cytoplast RTMTAPE, GIBSON Healthcare, MaxxTape, NEOTAPE, and Karl Schumacher Dental products. A total of 1,336 units were affected. The products were distributed through medical device distributors in Illinois, Indiana, Michigan, North Carolina, Ohio, and Texas.
The packaging may not be sealed, which could compromise sterility. This poses a risk of infection when the product is used in dental wound treatment procedures.
Patients and healthcare providers who have these products should stop using them and return them to the distributor or contact Collagen Matrix Inc. No injuries or illnesses have been reported to date.
The recalled product
- 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 Schuma
- Manufacturer
- Collagen Matrix Inc
- Hazard
- sterility-compromise
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1) UDI (1 unit package): +D765RTMTAPE100/$$3250131E1C0070AJ
- (10 units package): +D765RTMTAPE101/$$3250131E1C0080AK Cytoplast RTMTAPE
- REF 5251-194
- (10 units package): (01)10813954023578(17)250131(10)BDDWTU211002 MaxxTape
- Ref: XTAPE
- (5 units package): (01)10813954022076(17)250131(10)BDDWTU211002 NEOTAPE
- REF RCWT0001
- Lot BDDWTU211002
Distribution
Distributed in 6 states:
- IL
- IN
- MI
- NC
- OH
- TX
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