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FDA (Device enforcement)Recalled 2025-01-10class ii

Integra LifeSciences Corp.: Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Act

Hazard

Potential that the induction seal is not completely sealed to the device tube packaging.

Details from the source

Reason for recall: Potential that the induction seal is not completely sealed to the device tube packaging. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia. Quantity: 12,166 units Lot/code info: Model/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333;

UPC codes

10381780486886

Source

Official record: FDA (Device enforcement)

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

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