Rand S.r.l.
Country not established
- Devices
- 4
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Rand S.r.l. makes
Rand S.R.L. manufactures extracorporeal circulation systems, including the Hang&Go PAC and variations of the PERFORMER CPB system, designed for cardiac surgery and related procedures. These devices support cardiopulmonary bypass, providing oxygenation and circulation during open-heart operations. The portfolio also includes the PERFORMER HT and Hang&Go HT BASIC, tailored for specific intraoperative needs.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The portfolio is regulated in the United States, where Rand S.R.L. is based.
Catalogue
Hang&Go PAC Ref K161613
Regimes: 510(k) Registry: 510(k)Medtronic Performer Tm Cpb, Model R51, Pcpb Ref K052555
Regimes: 510(k) Registry: 510(k)Performer Cbp System Ref K070213
Regimes: 510(k) Registry: 510(k)Performer Ht/ Hang&Go Ht Basic Ref K120026
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Rand S.R.L., initiated on 2021-04-30. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 2
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 30 Apr 2021 Z-2048-2021 Class II Terminated The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
- 30 Apr 2021 Z-2049-2021 Class II Terminated The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
Frequently asked questions
How many devices does Rand S.R.L. have in the registry?
The registry currently lists 4 devices for Rand S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rand S.R.L.'s devices?
Among its 4 most recently registered devices, Rand S.R.L. has devices listed in FDA 510(k) (4 devices).
What risk classes do Rand S.R.L.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Rand S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rand S.R.L.?
FDA recall records list 2 recalls initiated by Rand S.R.L., the most recent initiated on 30 Apr 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Rand S.R.L. in the registry?
The most recently registered devices listed for Rand S.R.L. include Hang&Go PAC, MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB, PERFORMER CBP SYSTEM and PERFORMER HT/ HANG&GO HT BASIC.