FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
- Recall number
- Z-0190-2025
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
- Status
- Open, Classified
- Initiated
- 2024-09-24
- Posted
- 2024-10-23
- Terminated
- not on file
- 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
- 6590 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 50351688504041 (case), 10351688504043 (pouch), Lot Numbers: 4270150, 4277661, 4277716, 4287633
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DPT
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28