Reno, NV, United States
Ansell Healthcare Products LLC recalls
3 recalls recorded since 2018, most recently on 3 August 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 August 2023
- Reason
- Some surgical glove sterile pouches were not completely sealed.
- Distribution
- Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0097-2024, Z-0096-2024
- NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
- GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Ongoing Class II Medical devices
- Recall started
- 19 February 2022
- Reason
- Transport company failed to stop at the border for required FDA inspection.
- Distribution
- U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0838-2022
- Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Terminated Class II Medical devices
- Recall started
- 19 August 2020
- Terminated
- 3 November 2021
- Reason
- Examination gloves were shipped inadvertently, without to verify barrier integrity.
- Distribution
- U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0051-2021
- MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination b
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.