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"Your firms corrective actions only included scrapping devices in inventory and increasing the cleaning frequency of the [redacted] machine to prevent excess silicone from migrating to the luer connector, despite receiving 221 complaints and filing 177 [medical device reports (MDR)] for the disconnection of the NAMIC Angiographic Control Syringes from manifolds which impact patients and clinicians, including one (1) MDR # 3015910259-2025-00109 involving the injection of air into a patient (Complaint # [redacted] dated [redacted]) and one (1) MDR # 3015910259-2024-00045 involving biohazard exposure of a clinician (Complaint # [redacted] dated [redacted])." Furthermore, Medline Industries was cited for other violations, including failing to maintain schedules for adjusting, cleaning, and performing other equipment maintenance to ensure compliance with manufacturing specifications
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+34 965 79 36 18 Contctanos Llmanos +34 96 579 36 18 / +34 608 86 11 50 [email protected] Carrer de lHistoriador Palau, 18, 03730 Xbia, Alicante Horario de trabajo Lunes a Viernes: 8:00 AM-16:30 PM Siguenos Facebook-f Twitter Instagram El mejor servicio de limpiezas y desatascos de tuberas Dinos que necesitas y te hacemos un presupuesto personalizado
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