FDA Device recall Z-1302-2023
Atrium Pneumostat Chest Drain Valve, Part Number 16100
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Atrium Pneumostat Chest Drain Valve, Part Number 16100 by Atrium Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1302-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Reason
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.
Identifiers
| code_info | UDI-DI: 20650862161001; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 453404 455900 4582…UDI-DI: 20650862161001; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 453404 455900 458299 464069 455901 454344 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 463442 463443 463469 463586 463587 464069 464103 464104 464105 464669 464809 465368 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2023%22
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