Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a
Summary
The FDA issued a Class II for Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended fo by Cardinal Health. Reason: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied.
Details
Source
Device Recall
External ID
Z-0359-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
Lot/Code Info: UDI-DI: Each 10884521009455 Case 20884521009452 Lot Numbers: 2215000364
Quantity Affected: N/A
Reason for Recall
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-01
Company
Mansfield, MA
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 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cardinal Health has 20 FDA actions in our database, including 20 recalls.
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 (Cardinal Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health have FDA actions?
Cardinal Health has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0359-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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