HLS Set Advanced — Class II medical device recall Z-0633-2021
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2020-12-23, distributed nationwide. The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility
| Recall number | Z-0633-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2020-11-20 |
| Classified | 2020-12-17 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2024-11-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JO, JP, KR, KW, LB, LU, LV, MA, MX, MY, NL, NO, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TW, VN, ZA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04037691773513 |
| Lot numbers | 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038 |
| Model numbers | 70105.2794, 7050, 7050USA |
Product
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Reason for recall
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0633-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.