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Terminated

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

FDA Recall Z-1630-2018 · Posted None

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeFRO
Date Initiated2018-03-06
Date Terminated2018-07-30
Product Quantity766 cases

Reason for Recall

Incorrect gel part number listed in a master manufacturing record

Firm Action

Integra sent an Urgent Voluntary Medical Device Recall letter dated March, 6th, 2018 to distributor. The letter identified the affected product problem and actions to be taken. The letter instruct to complete and return the recall Acknowledgement form. For questions contact Customer Service at 1-800-854-2873. .

Root Cause

Manufacturing material removal

Distribution Pattern

US state of RI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101793MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEYDerma Sciences, Inc. · 2011-02-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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