Atrium Pneumostat Chest Drain Valve — Class II medical device recall Z-1302-2023
Ongoing recall by Atrium Medical Corporation, reported 2023-04-05, distributed nationwide. The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Dr
| Recall number | Z-1302-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CO, CZ, DE, EC, EE, ES, FI, FR, GB, HK, ID, IE, IL, IS, IT, JO, KR, KW, LU, MX, MY, NL, NO, NZ, PE, PH, PL, PT, SE, SG, SI, TH |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 20650862161001 |
| Lot numbers | 448618, 449703, 449992, 449993, 450923, 450924, 451439, 452012, 452013, 452575, 453404, 453472, 454260, 454344, 454345, 454589, 454803, 454850, 454851, 455359, 455360, 455370, 455898, 455900, 455901, 456447, 456448, 456904, 456905, 458298, 458299, 458300, 458301, 458642, 458643, 458644, 458645, 461545, 463439, 463441 and 12 more |
| Model numbers | 16100 |
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Reason for recall
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
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-1302-2023. 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.