Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Cathe
Pending LLM rewrite. Source: FDA_DEVICE Z-2460-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
The recalled product
- Product
- Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) 401211RH
- UDI-DI: 10197344043736(each)
- 10197344043736(case)
- Lot Number: EP250106
- 2) 401222RH
- UDI-DI: 10197344043712(each)
- 10197344043712(case)
- Lot Number: EP241118
- 3) 401222RH
- 4) 401223RH
- UDI-DI: 10197344043705(each)
- 10197344043705(case)
- 5) 401226RH
- UDI-DI: 10197344043699(each)
- 10197344043699(case)
- 6) 401226RH
- 7) 401227RH
- UDI-DI: 10197344043682(each)
- 10197344043682(case)
- 8) 401260RH
Distribution
Distributed nationwide across the United States.
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