FDA Recall
Terminated
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Recall: Z-0318-2021
·
Initiated June 24, 2019
Recall
- Recall Number
- Z-0318-2021
- Event Number
- 85124
- Firm
- OriGen Biomedical, Inc.
- FEI Number
- 1000160256
- Product Code
- KFM
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 24, 2019
- Terminated
- July 14, 2021
- Address
- 7000 Burleson Rd, Bldg D, Austin, TX, 78744-3202
Description
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Reason
The firm has become aware that they have distributed product that was expired.
Action
On 6/24/2019, a email was sent to the affected customer informing them that the product was expired and requesting that it be returned.
Distribution
US: TX
Quantity
6 units