Categories

Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to Patients

The Iso-Gard Filter S is a breathing circuit bacterial filter. It may split or detach preventing patients from getting sufficient supply of air.

http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-recalls-iso-gard-filter-s-risk-splitting-or-detaching-may-cause-leakage-and-insufficient

 
Categories

Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage – Letter to Health Care Providers

The FDA recommends health care providers discuss alternatives for MRI-guided breast biopsies with patients due to shortage of Philips Invivo plates and disposables.

http://www.fda.gov/medical-devices/letters-health-care-providers/consider-alternatives-mri-guided-breast-biopsy-grid-plates-due-shortage-letter-health-care-providers

 
Categories

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity

East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and