Z-0838-2022 Class II Ongoing
FDA device recall Z-0838-2022 was initiated by Ansell Healthcare Products LLC on February 19, 2022 and is designated Class II. Reason for recall: Transport company failed to stop at the border for required FDA inspection. The recall status is ongoing. Affected quantity: 74 cases.
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2022
- Initiation Date
- February 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 cases
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.
Distribution Pattern
U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
Code Information
Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604