Sorin Group USA, Inc.
Sorin Group USA, Inc. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2013, with 52 FDA device recalls on record.
Top product codes for Sorin Group USA, Inc.
FDA recalls by Sorin Group USA, Inc.
10 most recent of 52- Z-0076-2018 — FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
- Z-2776-2017 — STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
- Z-2775-2017 — STOCKERT Heater-Cooler System 3T, 120V/60 Hz
- Z-2773-2017 — STOCKERT Heater-Cooler System 3T, 208V/60 Hz
- Z-2772-2017 — STOCKERT Heater-Cooler System 3T, 240V/60 Hz
- Z-2771-2017 — STOCKERT Heater-Cooler System 3T, 230 V
- Z-2774-2017 — STOCKERT Heater-Cooler System 3T, 127V/60 Hz
- Z-2794-2017 — SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
- Z-2790-2017 — SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
- Z-2789-2017 — SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sorin Group USA, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.