FDA Device recall Z-0632-2021
HLS Set Advanced Model Name: BEQ-HLS 5050 USA
- FDA Device
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of HLS Set Advanced Model Name: BEQ-HLS 5050 USA by Maquet Cardiovascular Us Sales, citing the HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0632-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-20 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Reason
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Identifiers
| code_info | Model Number: BEQ-HLS 5050 Part Number: 70105.2797 UDI Code: 04037691773513 Lot Codes: 70127790, 70127791, 70127792,…Model Number: BEQ-HLS 5050 Part Number: 70105.2797 UDI Code: 04037691773513 Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921, 70127922, 70127923, 70127924, 70128195, 70128196, 70128197, 70128328, 70128329, 70128330, 70128331, 70129242, 70129243, 70129244, 70129245, 70129380, 70129381, 70129382, 70129383, 70129469, 70129470, 70129471, 70129472, 70129556, 70129557, 70129558, 70129559, 70129634, 70129635, 70129637, 70129638, 70129849, 70129850, 70130071, 70130072, 70130207, 70130208, 70130209, 70130883, 70130884, 70130885, 70130886, 70131090, 70131091, 70131092, 70131093, 70131159, 70131160, 70131161, 70131162, 70131405, 70131406, 70131407, 70131408, 70131474, 70131475, 70131587, 70131588, 70131589, 70131590, 70131976, 70131977, 70131978, 70131979, 70132435, 70132652, 70132653, 70132845, 70132861, 70132862, 70132903, 70132904, 70133056, 70133057, 70133102, 70133103, 70133472, 70133473, 70133474, 70133475, 70133528, 70133634, 70133636, 70133637, 70133751, 701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Maquet Cardiovascular Us Sales
- HLS Set Advanced, Model: BEQ-HLS 7050 USA
FDA Device · Class II · 2020-12-23 · Maquet Cardiovascular Us Sales - Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or…
FDA Device · Class II · 2020-11-18 · Maquet Cardiovascular Us Sales - Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical intervention…
FDA Device · Class II · 2020-10-28 · Maquet Cardiovascular Us Sales - Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical in…
FDA Device · Class II · 2020-10-28 · Maquet Cardiovascular Us Sales - Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that…
FDA Device · Class III · 2020-09-23 · Maquet Cardiovascular Us Sales
All Maquet Cardiovascular Us Sales recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0632-2021%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.