FDA issues warning letters to two breast implant manufacturers
Editor's Note The Food & Drug Administration (FDA) on March 19 issued warning letters to two breast implant manufacturers (Mentor Worldwide LLC of Irvine, California, and Sientra, Inc of Santa Barbara, California) for failing to comply with post-approval study requirements. All manufacturers of approved silicone gel-filled implants are required to…
FDA: Class I recall of Cook Medical’s Transseptal Needle
Editor's Note The Food and Drug Administration on March 18 identified the recall by Cook Medical Inc (Bloomington, Indiana) of one lot of its Transseptal Needles as Class I, the most serious. The recall was initiated because of a manufacturing error that resulted in some needle tips missing the back…
FDA: Hospira recalls 8.4% Sodium Bicarbonate Injection
Editor's Note The Food and Drug Administration (FDA) on March 15 announced the recall by Hospira, Inc (a Pfizer company) of three lots of its 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL). The recall was initiated because of the presence of particulate matter, confirmed as glass. The…
FDA: Guardian Pharmacy ordered to stop producing sterile compounded drugs
Editor's Note The Food & Drug Administration on March 12 announced that a federal judge entered a consent decree against Guardian Pharmacy Services (Dallas, Texas) to stop the company from producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic (FD&C)…
FDA issues letter on risks linked with staplers, implantable staples
Editor's Note The Food and Drug Administration (FDA) on March 8 issued a letter to alert healthcare providers about an increasing number of medical device reports on surgical staplers for internal use and implantable surgical staples. The most common reported problems include opening of the staple line, malformation of staples,…
FDA: Class I recall of RVO 2.0 Raindrop near vision inlay
Editor's Note The Food & Drug Administration (FDA) on March 5 identified the recall by RVO 2.0, Inc (Aliso Viejo, California) of its Raindrop near vision inlay as Class I, the most serious. All lots of the inlay are being recalled because data from the post-approval study showed an increased…
FDA issues Safety Communication on using surgical robots in women’s health
Editor's Note The Food and Drug Administration (FDA) on February 28 issued a Safety Communication on the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer in women. The FDA cited limited, preliminary evidence that the use of robotically-assisted surgical…
FDA: Class I recall of Physio-Control LIFEPAK 15 Monitor/Defibrillator
Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by Physio-Control, Inc (Redmond, Washington) of its LIFEPAK 15 Monitor/Defibrillator as Class I, the most serious. The recall was initiated because the device may “lockup” (freeze) after a shock is delivered. Once it freezes, it cannot…
FDA: Class I recall of ICU Medical’s ChemoLock Vial Spike
Editor's Note The Food & Drug Administration (FDA) on February 22 identified the recall by ICU Medical (San Clemente, California) of its ChemoLock Vial Spike (20 mm) as Class I, the most serious. The recall was initiated because of the potential for plastic particles to break off the protective cap.…
FDA: Class I recall of Smiths Medical Sterile Saline and Water for Inhalation
Editor's Note The Food & Drug Administration (FDA) on February 4 identified the recall by Smiths Medical (Minneapolis, Minnesota) of certain lots of Sterile Saline and Water for Inhalation as Class I, the most serious. The recall was initiated because of potential exposure to infectious agents (bacillus infantis and staphylococcus…
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