FDA Device recall Z-0634-2024
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
- FDA Device
- Class II
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class II recall of External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only by Natus Medical, citing sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0634-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-28 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Natus Medical |
| Distribution | US |
Product
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Reason
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Identifiers
| code_info | UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005…UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0634-2024%22
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