medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
FDA device recall Z-0193-2025 · posted 2024-10-23 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DPT
- Quantity affected
- 10 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-09-24
- Date posted
- 2024-10-23
- Location
- Minneapolis, MN
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