Day

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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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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