FDA Medical Device Recalls (openFDA)
OriGen Biomedical, Inc.: 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
- Recall number
- Z-0318-2021
- Recalling firm
- OriGen Biomedical, Inc.
- Product
- 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
- Status
- Terminated
- Initiated
- 2019-06-24
- Posted
- not on file
- Terminated
- 2021-07-14
- Reason
- The firm has become aware that they have distributed product that was expired.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 6 units
- Distribution
- US: TX
- Lot, serial or model codes
- Lot # 042417-5045
- 510(k) numbers
- ["K170029"]
- PMA numbers
- not on file
- Product code
- KFM
- Firm FEI
- 1000160256
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28