Maquet Cardiovascular Us Sales, Llc
Maquet Cardiovascular Us Sales, Llc appears in FDA public data with 62 recalls — including 7 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0633-2021, Class II) was initiated on November 20, 2020.
Summary
- Total Recalls
- 62 (7 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0633-2021 | Class II | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 | November 20, 2020 |
| Z-0632-2021 | Class II | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105 | November 20, 2020 |
| Z-0443-2021 | Class II | Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters | September 30, 2020 |
| Z-0132-2021 | Class II | Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediate | September 24, 2020 |
| Z-0133-2021 | Class II | Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, | September 24, 2020 |
| Z-2957-2020 | Class III | Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Ce | August 7, 2020 |
| Z-2780-2020 | Class II | Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: | June 18, 2020 |
| Z-1603-2020 | Class II | Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 | February 20, 2020 |
| Z-1475-2020 | Class II | Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: | February 10, 2020 |
| Z-1391-2020 | Class III | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facil | January 16, 2020 |
| Z-1390-2020 | Class III | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facil | January 16, 2020 |
| Z-0678-2020 | Class II | Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a compon | December 3, 2019 |
| Z-2149-2019 | Class II | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Numbe | July 11, 2019 |
| Z-1863-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF | May 28, 2019 |
| Z-1861-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF | May 28, 2019 |
| Z-1864-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF | May 28, 2019 |
| Z-1855-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP | May 28, 2019 |
| Z-1856-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP | May 28, 2019 |
| Z-1860-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM | May 28, 2019 |
| Z-1862-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF | May 28, 2019 |