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FDA Roundup: December 6, 2024

Murilo Freitas - 20:08, 5 de December de 202424

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

Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure

Murilo Freitas - 05:00, 5 de December de 202419

Newly manufactured Giraffe Omnibed and Incubator Carestations for neonates may put off higher than expected formaldehyde levels for the first week of use.

http://www.fda.gov/medical-devices/medical-device-recalls/neonatal-incubator-correction-ge-healthcare-updates-use-instructions-ge-healthcare-giraffe-omnibed

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 202430

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 202437

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 202432

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

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 202447

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 202442

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

Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets 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 202437

Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.

http://www.fda.gov/medical-devices/medical-device-recalls/peritoneal-dialysis-set-correction-baxter-issues-correction-minicap-extended-life-peritoneal

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 202444

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

FDA Roundup: November 26, 2024

Murilo Freitas - 19:40, 25 de November de 202438

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