Recall Z-1982-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1982-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-03

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-03. It names one FDA 510(k) clearance: K131796. Product: MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel. Reason: Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-05-03
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K131796 — MANUKA FILL WOUND DRESSINGLinks Medical Products, Inc.·cleared 2014-03-14

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

MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel

Reason for recall

Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.

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