HLS Set Advanced with BIOLINE Coating Custom tubing packs for the… — Class II medical device recall Z-1372-2016
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2016-04-20, distributed nationwide. Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endot
| Recall number | Z-1372-2016 |
|---|---|
| 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 | 2016-02-23 |
| Classified | 2016-04-12 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2019-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 72,000 units |
| Reason classes | sterility |
Product
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Reason for recall
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
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-1372-2016. 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.