Categories

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

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

 
Categories

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

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

 
Categories

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

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

 
Categories

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

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