Integra LifeSciences Corp. (NeuroSciences): Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONE

Hazard

Packaging failures were identified which could lead to a breach in the sterile barrier.

Details from the source

Reason for recall: Packaging failures were identified which could lead to a breach in the sterile barrier. 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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia. Quantity: 3583 units Lot/code info: Model/Catalog Number: (1) 31612, (2) 31622, (3) 31644; UDIs: (1) 10381780486947, (2) 10381780471356, (3) 10381780471363; lot#s: (1) D034323, (2) 50623, 45022, 34023, (3) 41223, 50423, 10323, 54223, 42323;

UPC codes

10381780486947, 10381780471356, 10381780471363

Source

Official record: FDA (Device enforcement) ↗

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