483
Medtronic CryoCath LPMedtronic CryoCath LP – FDA 483, Oct 31, 2024
Record Details
Medtronic CryoCath LP in Montreal received a Form FDA 483 following an inspection from October 28-31, 2024. The inspection revealed that finished medical devices, specifically the PulseSelect Pulsed Field Ablation Loop Catheter, were labeled as "Sterile" but had not undergone the sterilization process. The firm failed to properly identify these non-sterile devices, indicating a critical control deficiency in product acceptance and identification.
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ID · 5ab99a11-3857-47eb-9fec-e77ae07e0e59
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