Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Reported: April 2, 2025 Initiated: February 6, 2025 #Z-1460-2025
Product Description
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Reason for Recall
Devices may have higher than expected amounts of bacterial endotoxin.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 74 units
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 74 units.
Why was this product recalled? ▼
Devices may have higher than expected amounts of bacterial endotoxin.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2025. Severity: Moderate. Recall number: Z-1460-2025.
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