FDA Device recall Z-0813-2016
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product…
- FDA Device
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product… by Sorin Group Usa, citing sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0813-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-25 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Usa |
| Distribution | CA |
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
Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
Identifiers
| code_info | lot - 1529300018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0813-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.