Recall Z-0512-2019— Smiths Medical ASD Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2018-11-19, terminated 2020-06-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-19
- Terminated
- 2020-06-05
- Firm location
- Minneapolis, MN, United States
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.