ECMO Reinforced Dual Lumen Cannula — Class I medical device recall Z-1227-2019
Terminated recall by OriGen Biomedical, Inc., reported 2019-06-12, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between
| Recall number | Z-1227-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OriGen Biomedical, Inc., Austin, TX, United States |
| Recall initiated | 2017-01-17 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2021-07-27 |
| Distributed | 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 |
| Countries outside the US | AE, BE, CA, CL, CO, CZ, DE, ES, GB, IN, IT, JP, NL, PL, SA, SE, TH, ZA |
| Quantity | 260 |
| Lot numbers | N18446, N18640-1, R19208, R19406 |
| Model numbers | VV16F |
Product
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1227-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.