FDA Device recall Z-0147-2025
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000 by Smiths Medical Asd, citing uncertainty in the seal integrity of the sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0147-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-18 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Reason
Uncertainty in the seal integrity of the sterile packaging.
Identifiers
| code_info | a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI…a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169; b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057 |
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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-0147-2025%22
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