FDA Medical devices recall ·
Vista Brite Tip, Judkins Right 4 recall
- Recall number
- Z-1330-2025
- Date
- (initiated February 7, 2025)
- Company / brand
- Cordis US Corp
14201 Nw 60th Ave, Miami Lakes, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Why was it recalled?
Catheter manufactured at the incorrect length.
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
UDI: 20705032042991/ Lot Number: 18368326
Distribution
US: WA OUS: Japan
States: Washington
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-1330-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.