Integra LifeSciences Corp. (NeuroSciences): Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dres

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: 5374 units Lot/code info: Model/Catalog Number: (1) 31620, (2) 31640; UDIs: (1) 10381780471370, (2) 10381780471400; Lot#s: (1) 30623, 40724, 25022, 23823, 54922, 24123, 54322, 54023, 23024, 43823, 13424, (2) 24423, 53424, 11323, 51324, 10823, 20224, 30823, 24623, 33524, 34523;

UPC codes

10381780471370, 10381780471400

Source

Official record: FDA (Device enforcement) ↗

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