Summary
The FDA issued a Class II for Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R by Smiths Medical Asd Inc. Reason: There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized af.
Details
Source
Device Recall
External ID
Z-0742-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
Lot/Code Info: Lot Number: 4355397 4380735 4387234 4404740
Quantity Affected: 31,685 total
Reason for Recall
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-10
Company
Dublin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical Asd Inc has 164 FDA actions in our database, including 162 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical Asd Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical Asd Inc have FDA actions?
Smiths Medical Asd Inc has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0742-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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