Recall Z-1460-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-02-06. It names one FDA 510(k) clearance: K221067. Product: Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R. Reason: Devices may have higher than expected amounts of bacterial endotoxin..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-06
- Firm location
- Northfield, IL, United States
510(k) clearances named in this recall
1 on FDA's record- K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.