Medline ReNewal Reprocessed Electrophysiology Catheters May Contain Residual Particulates
Medline ReNewal reprocessed electrophysiology catheters may contain small residual particulates. The catheters were distributed nationwide to healthcare facilities.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall. The severity rubric requires that FDA Class I recalls score no lower than 4. Although no illnesses or injuries have been reported and the hazard is theoretical, the Class I designation alone justifies a minimum score of 4.
Plain-English summary
Medline Industries, LP is recalling specific lots of ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters because these catheters may contain small residual particulates. The recalled models include 401150RH, 401206RH, 401207RH, and many others, representing 398 units affected.
These catheters are reprocessed devices used in cardiac electrophysiology procedures. Residual particulates may remain from the reprocessing step if not fully removed during reprocessing.
Approximately 398 units of affected catheters were distributed nationwide to healthcare facilities. Specific affected lots include lot numbers EP241118 and EP250106 across various product models, identified by their UDI-DI codes in the full recall details.
Healthcare facilities should not use the affected catheters. Providers should check their inventory against the recalled lot numbers and model numbers listed in this recall and contact Medline Industries for guidance on handling affected devices.
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
- Hazard
- residual-particulates
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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