Supply Chain

Latest Issue of OR Manager
April 2019
Home Supply Chain/Technology > Supply Chain

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…

Read More

By: Judy Mathias
March 21, 2019
Share

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…

Read More

By: Judy Mathias
March 19, 2019
Share

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…

Read More

By: Judy Mathias
March 18, 2019
Share

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)…

Read More

By: Judy Mathias
March 14, 2019
Share

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…

Read More

By: Judy Mathias
March 6, 2019
Share

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…

Read More

By: Judy Mathias
February 28, 2019
Share

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.…

Read More

By: Judy Mathias
February 25, 2019
Share

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…

Read More

By: Judy Mathias
February 21, 2019
Share

Disruptive innovation in supply chain: Impact of Amazon Business and technology, Part 2

Supply chain is ripe for innovation, as Amazon Business and technology manufacturers have discovered. In part 1 of this two-part series, we focused on the company’s role in the supply chain (OR Manager, February 2019, 1, 9-12). In part 2, we look at technology-related trends and innovations that can improve…

Read More

By: Cynthia Saver, MS, RN
February 20, 2019
Share

FDA: Class I recall of Medtronic’s Dual Chamber Implantable Pulse Generators

Editor's Note The Food & Drug Administration (FDA) on February 15 identified Medtronic, Inc’s (Dublin, Ireland) recall of it’s Dual Chamber Implantable Pulse Generators (IPGs) as Class I, the most serious. The recall was initiated because of the possibility of a software error that can result in a lack of…

Read More

By: Judy Mathias
February 19, 2019
Share
Live chat by BoldChat