Recall Z-0199-2025
Smiths Medical ASD, Inc. · initiated September 24, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Codes / lots: UDI/DI 50351688503068 (case), 10351688503060 (pouch), Lot Numbers: 4323136
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0199-2025
- Initiated
- September 24, 2024
- Posted by FDA
- October 23, 2024
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Quantity
- 250 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Smiths Medical ASD, Inc., Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0182-2025 Class II | medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0183-2025 Class II | medex TranStar Single ICP Set 1/EA, Product Code REF MX20897Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0184-2025 Class II | medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0185-2025 Class II | medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0186-2025 Class II | medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0187-2025 Class II | medex Arterial Kit 1/EA, Product Code REF MX7827Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0188-2025 Class II | medex TranStar Disposable Transducer 1/EA, Product Code REF MX950Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0189-2025 Class II | medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0190-2025 Class II | medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0191-2025 Class II | medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0192-2025 Class II | medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0193-2025 Class II | medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFTDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0194-2025 Class II | medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNTDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0195-2025 Class II | medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SCDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0196-2025 Class II | medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0197-2025 Class II | medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0198-2025 Class II | medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0200-2025 Class II | medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0201-2025 Class II | medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0202-2025 Class II | medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0203-2025 Class II | medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0204-2025 Class II | medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |
| Z-0205-2025 Class II | smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | 09/24/2024Open, Classified |