FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.
- Recall number
- Z-1477-2021
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.
- Status
- Terminated
- Initiated
- 2021-03-31
- Posted
- 2021-04-21
- Terminated
- 2023-03-20
- Reason
- Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
- Root cause
- Process control
- Action
- The firm initiated the action by email on 03/31/2021. The Recall Notice instructs consignees to identify, and quarantine affected product in their possession. A list of affected product has been included on the Recall Notice for consignees to identify affected product. The consignees have been instructed to complete the response form, and return it to fieldactions@smiths-medical.com within 10 days of receipt. After the completed Recall Response Form has been submitted to fieldactions@smiths-medical.com, the consignee will be contacted to arrange return of any affected product in their possession. Distributors have been instructed that if they have distributed potentially affected product to their customers to immediately notify them of the Recall.
- Quantity
- 3825 units
- Distribution
- Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
- Lot, serial or model codes
- a. Model Number MX1431MR, Lot Numbers: 3995544 b. Model Number MX1431MRL, Lot Numbers: 3995545, 4011838, 4027758, 4033501, 4044959 c. Model Number MX4331R, Lot Numbers: 3971467, 3987918
- 510(k) numbers
- ["K961404"]
- PMA numbers
- not on file
- Product code
- DRS
- 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