Recall Z-1231-2019— OriGen Biomedical, Inc.
Class I · Terminated
Class I FDA medical device recall by OriGen Biomedical, Inc., initiated 2017-01-17, terminated 2021-07-27. It names one FDA 510(k) clearance: K113869. Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F. 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..
- Recalling firm
- OriGen Biomedical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-01-17
- Terminated
- 2021-07-27
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.