FDA recall Z-1630-2018

Integra LifeSciences Corp. · Class II · device

Product

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

Reason for recall

Incorrect gel part number listed in a master manufacturing record

Distribution

US state of RI

Key facts

Status
Terminated
Initiation date
2018-03-06
Report date
2018-05-16
Termination date
2018-07-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plainsboro, NJ, United States

Primary source

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