Medical device recalls Moderate risk

Integra LifeSciences product recalled over laceration hazard

Recall date
March 6, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Integra LifeSciences Corp. recalls Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to…
Recall number
Z-1630-2018
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp.
Sold / distributed
US state of RI

Why it was recalled

Incorrect gel part number listed in a master manufacturing record

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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