Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider for instructions. Notification method: Letter
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Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.. Reason: Increased rate of out-of-specification endotoxin results.. Classification: Class II. Quantity: 226 units. Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
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