FDA Medical devices recall ·
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions… recall
- Recall number
- Z-0422-2026
- Date
- (initiated October 17, 2025)
- Company / brand
- Mozarc Medical US LLC
15 Hampshire St, Mansfield, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,258 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Why was it recalled?
A potential issue with the seal integrity of header bag packaging.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF Number: 8888101002HP; UDI-DI: (Individual unit) 10884521127968, (Carton) 20884521127965; Lot number: 2430500017;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0422-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.