Recall Z-0096-2024— Ansell Healthcare Products LLC

Name: FDA recall Z-0096-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-03

Class II · Ongoing

Class II FDA medical device recall by Ansell Healthcare Products LLC, initiated 2023-08-03. It names one FDA 510(k) clearance: K111139. Product: GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290. Reason: Some surgical glove sterile pouches were not completely sealed..

Recalling firm: Ansell Healthcare Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-08-03
Firm location: Reno, NV, United States

510(k) clearances named in this recall

1 on FDA's record

K111139 — DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR UAnsell Healthcare Products, Inc.·cleared 2011-09-02

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

GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

Reason for recall

Some surgical glove sterile pouches were not completely sealed.

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