Murilo Freitas – Page 19 – PRAIS 2.0

Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems – Letter to Health Care Providers

Murilo Freitas - 05:00, 8 de December de 2024205

The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns.

http://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-availability-concerns-vasoview-hemopro-endoscopic-vessel-harvesting-systems-letter-health

FDA Roundup: December 6, 2024

Murilo Freitas - 20:08, 5 de December de 2024177

FDA Roundup: December 6, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-6-2024

Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors

Murilo Freitas - 05:00, 3 de December de 2024173

Monoject U-100 1 ml Insulin Syringe Luer-Lock with Tip Cap Soft Pack is used for IV insulin. Certain lots are incompatible with needleless connectors.

http://www.fda.gov/medical-devices/medical-device-recalls/syringe-recall-cardinal-health-removes-certain-monoject-u-100-ml-insulin-syringe-luer-lock-tip-cap

FDA Roundup: December 3, 2024

Murilo Freitas - 20:52, 2 de December de 2024170

FDA Roundup: December 3, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-3-2024

USDA-FDA Seek Information About Food Date Labeling, Aim is to Provide Further Clarity, Transparency and Cost Savings for U.S. Consumers

Murilo Freitas - 18:08, 2 de December de 2024157

USDA-FDA Seek Information About Food Date Labeling, Aim is to Provide Further Clarity, Transparency and Cost Savings for U.S. Consumers
http://www.fda.gov/news-events/press-announcements/usda-fda-seek-information-about-food-date-labeling-aim-provide-further-clarity-transparency-and-cost

Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs

Murilo Freitas - 05:00, 28 de November de 2024172

Use of Baxter AK 98 hemodialysis machines with less than 500 hours of run time may expose patients to higher than allowable NDL-PCBAs.

http://www.fda.gov/medical-devices/medical-device-recalls/hemodialysis-correction-baxter-issues-correction-ak-98-hemodialysis-machines-due-risk-patient

Insertion Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to a Manufacturing Size Error That May Lead to Patient Harm

Murilo Freitas - 05:00, 28 de November de 2024170

FHC microTargeting Insertion Tube Sets guide instruments during neurosurgery. The reducing cannula in a specific lot is 20mm too long.

http://www.fda.gov/medical-devices/medical-device-recalls/insertion-tube-recall-fhc-removes-microtargeting-insertion-tube-sets-due-manufacturing-size-error

Biopsy Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to Risk of Microscopic Stainless Steel Debris Inside Needle

Murilo Freitas - 05:00, 28 de November de 2024163

Disposable Biopsy Needle Kit is used in neurosurgery but a specific batch of kits may have microscopic stainless steel debris inside.

http://www.fda.gov/medical-devices/medical-device-recalls/biopsy-needle-recall-elekta-removes-disposable-biopsy-needle-kits-due-risk-microscopic-stainless

FDA Roundup: November 26, 2024

Murilo Freitas - 19:40, 25 de November de 2024149

FDA Roundup: November 26, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-26-2024

FDA Roundup: November 22, 2024

Murilo Freitas - 19:49, 21 de November de 2024153

FDA Roundup: November 22, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-22-2024

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