Z-0318-2021 Class II Terminated
FDA device recall Z-0318-2021 was initiated by OriGen Biomedical, Inc. on June 24, 2019 and is designated Class II. Reason for recall: The firm has become aware that they have distributed product that was expired. The recall status is terminated (terminated July 14, 2021). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- June 24, 2019
- Termination Date
- July 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Reason for Recall
The firm has become aware that they have distributed product that was expired.
Distribution Pattern
US: TX
Code Information
Lot # 042417-5045