Recall Z-0512-2019 ยท FMG Stopcock, I.V. Set
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.
| Date | Nov 19, 2018 |
| Status | Terminated |
| 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 F |
| Quantity | 2,425 devices |
| Distribution | The potentially affected products were shipped to customers in the US, Canada, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.