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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.