FDA Device recall Z-1051-2024
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
- FDA Device
- Class I
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class I recall of Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD by Cardinal Health 200, citing convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1051-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-04 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | n/a |
Product
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Reason
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Identifiers
| code_info | 7946, UDI/DI 20884521029559 (cs), 10884521029552 (ea), Lot Numbers: 2222832064, 2301031864, 2317001864, 2209526164, 22…7946, UDI/DI 20884521029559 (cs), 10884521029552 (ea), Lot Numbers: 2222832064, 2301031864, 2317001864, 2209526164, 2215827064, 2317731864, 2305204964, 2305205064, 2210226764, 2208817764 |
|---|
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-1051-2024%22
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