Sorin Group USA, Inc.
Sorin Group USA, Inc. appears in FDA public data with 52 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0076-2018, Class II) was initiated on September 28, 2017. Its most recent 510(k) clearance was granted on May 21, 2013.
Summary
- Total Recalls
- 52
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0076-2018 | Class II | FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use st | September 28, 2017 |
| Z-2771-2017 | Class II | STOCKERT Heater-Cooler System 3T, 230 V | June 30, 2017 |
| Z-2775-2017 | Class II | STOCKERT Heater-Cooler System 3T, 120V/60 Hz | June 30, 2017 |
| Z-2773-2017 | Class II | STOCKERT Heater-Cooler System 3T, 208V/60 Hz | June 30, 2017 |
| Z-2774-2017 | Class II | STOCKERT Heater-Cooler System 3T, 127V/60 Hz | June 30, 2017 |
| Z-2772-2017 | Class II | STOCKERT Heater-Cooler System 3T, 240V/60 Hz | June 30, 2017 |
| Z-2776-2017 | Class II | STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz | June 30, 2017 |
| Z-2795-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2798-2017 | Class II | NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE | June 29, 2017 |
| Z-2790-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2791-2017 | Class II | STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, | June 29, 2017 |
| Z-2797-2017 | Class II | NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR | June 29, 2017 |
| Z-2793-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2794-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2787-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2792-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2784-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only | June 29, 2017 |
| Z-2789-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2786-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA | June 29, 2017 |
| Z-2788-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) | June 29, 2017 |