FDA Device recall Z-1232-2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
- FDA Device
- Class I
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class I recall of ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F by Origen Biomedical, citing 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 whil….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1232-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-01-17 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Origen Biomedical |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WI |
Product
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
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.
Identifiers
| code_info | Lots: N18487, N18487-1, N18561-1, R19169 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1232-2019%22
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