Recall Z-0838-2022— Ansell Healthcare Products LLC

Name: FDA recall Z-0838-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-19

Class II · Ongoing

Class II FDA medical device recall by Ansell Healthcare Products LLC, initiated 2022-02-19. It names one FDA 510(k) clearance: K111139. Product: Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2. Reason: Transport company failed to stop at the border for required FDA inspection..

Recalling firm: Ansell Healthcare Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-02-19
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 PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Reason for recall

Transport company failed to stop at the border for required FDA inspection.

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