—#169042

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.

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)

Why it was recalled

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 (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: The potentially affected products were shipped to customers in the US, Canada, and Mexico.

Timeline

Recall initiated: 2018-11-19
Terminated: 2020-06-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169042. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.