Recall Z-0185-2025 ยท DPT Probe, Blood-Flow, Extravascular
Smiths Medical ASD, Inc.
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
| Date | Oct 23, 2024 (initiated Sep 24, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers. |
| Quantity | 400 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942377 | TRANSTAR PRESSURE TRANSDUCER Medex, Inc., Aug 16, 1994 |