FDA-Device2018-05-16Class II

Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions

Integra LifeSciences Corp.
Hazard

Incorrect gel part number listed in a master manufacturing record

Sold states
US state of RI
Affected count
766 cases
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1630-2018

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