Customer Service: 1-800-331-7993
November 10, 2014
The FDA has notified health professionals and their medical care organizations of the Class 1 recall of the Puritan Bennett 980 Ventilator Systems with software versions below 2.8, with distribution dates March 3, 2014 through August 22, 2014 and serial numbers listed here. The recalled products have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected, which could lead to serious health problems or death.
RECOMMENDATION: Covidien sent an Urgent Field Corrective Action letter dated October 3, 2014 to its customers. A Covidien representative will update the software on the ventilators as soon as possible. To receive the software update, complete the acknowledgement and receipt form attached to the correction letter. Fax it to the Covidien contact found on the form.
Customers may continue to use these ventilators until Covidien updates the software, as long as two gas sources are connected to the ventilator at all times. See the recall notice at the link below for other Covidien reminders and instructions from the Corrective Action letter.
Read the MedWatch safety alert including a link to the Recall Notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm422362.htm
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
October 8, 2014
The FDA has announced a report that the ends of the Hudson RCI Anesthesia Breating Circuits may crack or break before or during use. This could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.
Manufacturing Dates: March 2013 to July 2014
Distribution Dates: June 2013 to May 2014
RECOMMENDATION: On September 8, 2014, Teleflex Medical sent customers an Urgent Medical Device Recall letter explaining the device problem and actions to be taken. See complete list of recalled devices.
Teleflex Medical recommends the following actions:
July 31, 2014
Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide.
Check the lot numbers of your inventory to see if you have any affected product and contact Hospira or your dealer for instructions on exchanging the affected product.