FDA: Class I recall of Arrow central venous access and catheter kits
Editor's Note The Food and Drug Administration (FDA) on December 16 identified the recall by Teleflex and Arrow International, LLC, of its Arrow MAC Two-Lumen Central Venous Access Kits and Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits as Class I, the most serious. The recall…
FDA: Exela Pharma Sciences, LLC, expands recall of Sodium Bicarb
Editor's Note The Food and Drug Administration (FDA) on November 29 posted Exela Pharma Sciences’ expansion of its recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. The product poses a safety concern because of vial breakage with flying glass when pressurized while preparing the product for…
FDA: Class I recall of Dewei Medical Equipment’s DNA/RNA Preservation Kits
Editor's Note The Food and Drug Administration (FDA) on December 8 identified the recall by Dewei Medical Equipment Co of its DNA/RNA Preservation Kits as Class I, the most serious. The kits are used to collect, preserve, and transport clinical samples that will be tested for viruses, including COVID-19. The…
FDA: Class I recall of Baxter Hillrom WatchCare IMS for RF interference risk
Editor's Note The Food and Drug Administration, on November 23, identified the recall by Baxter Hillrom of its WatchCare Incontinence Management System (IMS) as Class I, the most serious. The recall was initiated because of the risk for radiofrequency (RF) emissions from WatchCare devices that may interfere with other devices,…
FDA: Class I recall of Insulet Omnipod DASH PDM
Editor's Note The Food and Drug Administration (FDA) on November 16 identified the recall by Insulet of its Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) as Class I, the most serious. The recall was initiated because of PDM battery issues, including: Battery swelling Fluid leakage from the battery…
Supply chain expert warns that drug shortages will persist
Editor's Note Vials of the chemotherapy drug fludarabine could be purchased at a whole sale price of $110 last year—today, it is being sold for a much higher price, Fierce Pharma November 1 reports. One company, Areva Pharmeceuticals, increased the price to $2,736, Stat News reported on October 27. This…
FDA: Class I recall of Teleflex Iso-Gard Filter S
Editor's Note The Food and Drug Administration (FDA) on November 1 identified the recall of Teleflex’s Iso-Gard Filter S as Class I, the most serious. Iso-Gard filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in operating rooms and ICUs. The recall was initiated…
FDA issues Safety Communication on tracheostomy tube shortages
Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Medical Device Safety Communication on tracheostomy tube shortages. Included in the shortages are Bivona tracheostomy tubes manufactured by ICU Medical, which are more likely to affect pediatric patients. Also on the shortage list are JOH Tube Tracheostomy…
FDA: Five companies are having amoxicillin shortages
Editor's Note As of November 1, the Food and Drug Administration (FDA) listed 26 amoxicillin products on its current drug shortages site. The FDA says increased demand is the largest cause of the shortage. The FDA does not list resupply dates, but the American Society of Health-System Pharmacists (ASHP) estimates…
FDA: Class I recall of Jiangsu Well Biotech COVID-19 Ag Rapid Test
Editor's Note The Food and Drug Administration (FDA) on October 12 identified the recall of Jiangsu Well Biotech’s COVID-19 Ag Rapid Test Devices as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA. No…
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