FDA Device recall Z-1303-2023
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Express Mini 500 Dry Seal Chest Drain, Part Number 16400 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-1303-2023 |
| 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
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
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: 00650862164008; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 477059 478375…UDI-DI: 00650862164008; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 477059 478375 481999 483536 484044 485782 486195 477059 478375 481105 485782 449700 450921 451436 460632 463584 463585 464668 472965 472969 473749 477059 445024 448992 449700 449990 450921 450922 451436 452010 452011 452574 453402 460620 460621 460629 460630 460631 460632 460633 460787 461043 461333 461336 461337 461821 461822 461823 461824 461940 462215 462487 462489 463584 463585 464101 464102 464667 464668 465132 465138 465516 465517 465667 465668 472838 472965 472966 472969 473749 475492 477059 477985 475492 477059 478375 481105 481998 482573 485782 486195 486195 474692 475492 477059 478375 480643 481104 481105 481998 481999 482001 482572 482573 483028 483536 484044 485782 486195 487568 487569 487570 488316 489338 489 |
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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-1303-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.