FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
- Recall number
- Z-0512-2019
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
- Status
- Terminated
- Initiated
- 2018-11-19
- Posted
- not on file
- Terminated
- 2020-06-05
- Reason
- Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
- Root cause
- Equipment maintenance
- Action
- Smiths Medical notified customers on about 11/19/2018 via email with the attached "URGENT MEDICAL DEVICE RECALL NOTICE." Distributors were instructed to immediately notify customers to whom they have distributed affected product to of the Recall Notice. They were also instructed to follow the following steps: 1. Locate affected product in your possession by referring to the attached Response Form. This form identifies specific affected product that Smiths Medical shipped to your facility. 2. Determine the number of affected devices in your possession and complete the attached Response Form within 10 days of receipt, returning it to fieldactions@smiths-medical.com. This form must be returned even if you do not have any affected product in your possession. 3. Upon receipt of the completed Response Form, a shipping label will be issued to you for use in returning your affected product for processing. Package the affected products securely and include a copy of the completed Response Form inside each box, ensuring boxes are sealed and labeled with your facility name prior to shipping. Credit will be processed when your completed Response Form is received and once returned affected products have been processed.
- Quantity
- 2,425 devices
- Distribution
- The potentially affected products were shipped to customers in the US, Canada, and Mexico.
- Lot, serial or model codes
- Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMG
- 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