Recall Z-1630-2018— Integra LifeSciences Corp.

Name: FDA recall Z-1630-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-06

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2018-03-06, terminated 2018-07-30. It names one FDA 510(k) clearance: K101793. 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: Incorrect gel part number listed in a master manufacturing record.

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2018-03-06
Terminated: 2018-07-30
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K101793 — MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEYDerma Sciences, Inc.·cleared 2011-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.