Atrium Pneumostat Chest Drain Valve — Class II medical device recall Z-2592-2021
Ongoing recall by Atrium Medical Corporation, reported 2021-10-06, distributed nationwide. The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device wa
| Recall number | Z-2592-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2021-08-26 |
| Classified | 2021-09-29 |
| Reported by FDA | 2021-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 92,430 units |
| Lot numbers | 432585, 433297, 433298, 433692, 433693, 433974, 434040, 434962, 435659, 435660, 435699, 436106, 436107, 437111, 437530, 438520, 439396, 439891, 439905, 440201, 441182, 441183, 441184, 441185, 441392, 441553, 441554, 443330, 443362, 443849, 443968, 445021, 446022, 447065, 447066, 448138, 448139, 448203, 448618, 448995 and 58 more |
| Model numbers | 16100 |
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Reason for recall
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
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-2592-2021. 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.