Dual Stage Venous Return Catheter — Class II medical device recall Z-0813-2016
Terminated recall by Sorin Group USA, Inc., reported 2016-02-24, distributed in CA. Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instruc
| Recall number | Z-0813-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2016-01-25 |
| Classified | 2016-02-16 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2016-10-24 |
| Distributed | CA |
| Countries outside the US | CA |
| Quantity | 60 |
| Lot numbers | 1529300018 |
| Model numbers | LRD-61046 |
| Expiration dates | 2018-10-31 |
Product
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
Reason for recall
Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
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-0813-2016. 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.