Z-0512-2019 Class II Terminated
FDA device recall Z-0512-2019 was initiated by Smiths Medical ASD Inc. on Nov 19, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 5, 2020). Affected quantity: 2,425 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 5, 2018
- Initiation Date
- Nov 19, 2018
- Termination Date
- Jun 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,425 devices
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
Distribution Pattern
The potentially affected products were shipped to customers in the US, Canada, and Mexico.
Code Information
Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0512-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026