FDA Medical Device Recalls (openFDA)
OriGen Biomedical, Inc.: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
- Recall number
- Z-1229-2019
- Recalling firm
- OriGen Biomedical, Inc.
- Product
- ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
- Status
- Terminated
- Initiated
- 2017-01-17
- Posted
- 2019-06-04
- Terminated
- 2021-07-27
- Reason
- Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
- Root cause
- Process control
- Action
- On 01/17/2017, Technical Bulletin 17.01 was mailed to customers. Customers were informed to clamp all sizes of catheters only in the middle. The following contact information was provided: US: 1-512-474-7278, and Germany: +49-7475-915591.
- Quantity
- 66
- Distribution
- US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
- Lot, serial or model codes
- Lots: P18806, R19368
- 510(k) numbers
- ["K113869"]
- PMA numbers
- not on file
- Product code
- DWF
- 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