Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots
Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this reprocessed catheter action as Class I.
Plain-English summary
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters are being recalled across model numbers including 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH and 401271RH. Affected lots are listed per model in the recall notice, including lot EP250106 for model 401211RH. The recall covers 398 units distributed nationwide in the United States.
The recall was issued because specific lots of reprocessed electrophysiology catheters may contain small residual particulates. The FDA classified the action as Class I, the agency's most serious category.
Hospitals and electrophysiology labs holding these model and lot numbers should quarantine affected stock and follow the manufacturer's instructions for return.
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
- Affected units
- 398
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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