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Recall Observatory FDA recall evidence

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

Z-1630-2018

March 06, 2018

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 79765
Status
Terminated
Classification
Class II
Quantity
766 cases
Official record key
device-enforcement:Z-1630-2018

Official wording

Reason: Incorrect gel part number listed in a master manufacturing record

Code information: Lot# 1610; 1621; 1639; 1737; 1745

Distribution pattern: US state of RI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect gel part number listed in a master manufacturing record