Z-0512-2019Class II

Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for...

Name: Z-0512-2019 Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for...
Creator: Smiths Medical ASD Inc.
Published: 2018-11-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-11-19 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2018-11-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0512-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-19
Posted: 2019-07-05
Terminated: 2020-06-05
Recalling firm: Abbott Medical
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.
Product code: FMG Stopcock, I.V. Set
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
Root cause tag: manufacturing process
FDA 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 Form within 10 days of receipt, returning it to [email protected]. 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.
Product codes and lots: Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0512-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0512-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28

Product code FMG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)