MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24
Summary
The FDA issued a Class II for MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions wit by Mozarc Medical US LLC. Reason: A potential issue with the seal integrity of header bag packaging..
Details
Source
Device Recall
External ID
Z-0425-2026
Action Date
2025-11-12
Status
Ongoing
Category
device
Product Description
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Lot/Code Info: REF Number: 8888102004HP; UDI-DI: (Individual unit) 10884521128002, (Carton) 20884521128009; Lot number: 2424500197;
Quantity Affected: 3,258 units
Reason for Recall
A potential issue with the seal integrity of header bag packaging.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-17
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 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mozarc Medical US LLC has 12 FDA actions in our database, including 12 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 (Mozarc Medical US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mozarc Medical US LLC have FDA actions?
Mozarc Medical US LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0425-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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