Product REF 4000-100N — Class I medical device recall Z-0709-2024
Ongoing recall by Maquet Cardiovascular, LLC, reported 2024-01-24, distributed nationwide. Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is n
| Recall number | Z-0709-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2023-12-13 |
| Classified | 2024-01-12 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, ES, GB, LU, NL, NO |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00650862115130 |
| Lot numbers | 466080, 466267, 466455, 466637, 466951, 467193, 467194, 467195, 467352, 467475, 467476, 468395, 468856, 468857, 468858, 469402, 469403, 469918, 469919, 469920, 470148, 471069, 471805, 471806, 472581, 473747, 474076, 474077, 474511, 474950, 474967, 474982, 475228, 475487, 477950, 483107, 483108, 483180, 483533, 483534 and 32 more |
| Model numbers | 4000-100N |
Product
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Reason for recall
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
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-0709-2024. 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.