Editor's Note The Food and Drug Administration (FDA) on August 4 classified the recall by Datascope Corp/Maquet (Mahwah, New Jersey) of its intra-aortic balloon pump as Class I, the most serious. The recall was issued because of the risk of a valve failure, which prevents the balloon from inflating and…

Read More

Editor's note The Food and Drug Administration (FDA) on July 31 announced the recall by ICU Medical, Inc (San Clemente, California) of one lot of 0.9% sodium chloride injection, USP 1,000 mL. The recall was issued because of a confirmed customer complaint of particulate matter identified as stainless steel in…

Read More

Editor's Note The Food and Drug Administration (FDA) on July 21 announced the recall by Fujifilm of its ED-530XT duodenoscopes. The recall includes replacement of the ED-530XT forceps elevator mechanism including the o-ring seal, replacement of the distal end cap, and a new operations manual. The FDA cleared the updated…

Read More

Editor's Note The Food and Drug Administration (FDA) on July 6 announced the recall by Oscor Inc (Palm Harbor, Florida) of its Atar extension cables. The recall was initiated because, during use, some of the cables were separating from the connectors at the proximal end. The Atar cable is an…

Read More

Editor's Note The Food and Drug Administration (FDA) on June 30 issued a draft guideline: “Product Identifier Requirements Under the Drug Supply Chain Security Act−Compliance Policy.” The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a…

Read More

Editor's Note The Food and Drug Administration on June 27 announced the recall by PharMEDium Services of specific lots of potassium phosphate and succinylcholine chloride because of a lack of sterility assurance. The products being recalled were compounded using certain Hospira products, which were recalled on June 15 because microbial…

Read More

Editor's Note The Food and Drug Administration (FDA) on June 23 posted the recall by Fagron Sterile Services (Wichita, Kansas) of three lots of succinylcholine chloride 20 mg/mL 5 mL syringes because of microbial growth detected during a simulation of the manufacturing process. This is a secondary recall of products…

Read More

Editor's Note The Food and Drug Administration (FDA) on June 21 announced the recall by Vascular Solutions (Maple Grove, Minnesota) of its Venture Catheters. The recall was initiated because there is a risk of the catheter tip splitting or separating during use and entering the patient’s bloodstream. This can result…

Read More

Editor's Note The Food and Drug Administration (FDA) on June 16 announced the recall by Alvogen/Hospira Inc, a Pfizer company, of seven lots of Clindamycin Injection USP ADD-Vantage Vials. The recall was initiated because microbial growth was detected during a routine simulation of the manufacturing process, which represents the potential…

Read More

Editor's Note The Food and Drug Administration (FDA) on June 19 announced the recall by Maquet/Datascope (Fairfield, New Jersey) of its System CS100, CS100i, and CS300 Intra-Aortic Balloon Pumps. The recall also applies to System 98 or System 98XT IABP that was converted to a CS100i or CS 300 IABP.…

Read More