medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr… — Class II medical device recall Z-0200-2025
Ongoing recall by Smiths Medical ASD, Inc., reported 2024-10-30. Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressur
| Recall number | Z-0200-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Minneapolis, MN, United States |
| Recall initiated | 2024-09-24 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Quantity | 3,280 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10351688503015, 50351688503013 |
| Lot numbers | 4223699, 4248326, 4297927, 4323137, 4340498, 4346068, 4350022 |
| Model numbers | MX9547 |
Product
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Reason for recall
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0200-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.