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U.S. Department of Health and Human Services

Class 2 Device Recall Medex stopcocks and manifolds

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  Class 2 Device Recall Medex stopcocks and manifolds see related information
Date Initiated by Firm November 19, 2018
Create Date July 05, 2019
Recall Status1 Terminated 3 on June 05, 2020
Recall Number Z-0512-2019
Recall Event ID 81599
Product Classification Stopcock, i.V. Set - Product Code FMG
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.
Code Information Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer 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
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 2,425 devices
Distribution The potentially affected products were shipped to customers in the US, Canada, and Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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