January 22, 2020
Company: Degania Silicone, Ltd. Date of Enforcement Report: 1/22/2020 Class II PRODUCT Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage. Recall Number: Z-0809-2020 REASON Temperature deviation did not meet release specifications. RECALLING FIRM/MANUFACTURER Degania Silicone,...
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Company: St Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report: 1/22/2020 Class II PRODUCT Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. – Product Usage:...
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Company: GE Healthcare, LLC Date of Enforcement Report: 1/22/2020 Class I PRODUCT CARESCAPE Respiratory Module E-sCO Recall Number: Z-0754-2020 CARESCAPE Respiratory Module E-sCOVX Recall Number: Z-0755-2020 CARESCAPE Respiratory Module E-sCAiO Recall Number: Z-0756-2020 CARESCAPE Respiratory Module E-sCAiOV Recall Number: Z-0757-2020 CARESCAPE Respiratory Module E-sCAiOE Recall Number: Z-0758-2020 CARESCAPE Respiratory Module E-sCAiOVE Recall Number: Z-0759-2020 Airway...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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