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Bag Medical Device - Articles

Class I Medical Device Recall: Westmed Inc., BagEasy Manual Resuscitation Devices by FDA Posted Tue 12 Oct 2010 9:00pm Recall Class: Class I Date Recall Initiated: June 22, 2010 Products: BagEasy Manual Resuscitation Devices To find all the part and lot numbers and the specific descriptions of the devices affected by this recall, see the Firm Press Release under Useful Links below. Use: This type of manual emergency resuscit ... Read on »
Study suggests that being too clean can make people sick by Karen Bastille Health Maven Posted Mon 29 Nov 2010 2:07pm EurekaAlert Young people who are overexposed to antibacterial soaps containing triclosan may suffer more allergies, and exposure to higher levels of Bisphenol A among adults may negatively influence the immune system, a new University of Michigan School of Public Health study suggests. Triclosan is a chemical compoun ... Read on »
Chemical Found in Medical Devices Linked to Heart Problems - Cyclohexanone by Medical Quack Patient ExpertHealth Maven Posted Sat 09 May 2009 10:41pm The loss of memory and/or taste that can occur following bypass surgery has been a mystery and it appears to be the chemical in the tubing , IV bags and catheters.  Perhaps we might see some changes down the road in the manufacturing processes with plastics.  This has not been the only issue with plastic products as the heated discussion on BPA ... Read on »
Time For A Renewed Focus With Bar Codes For FDA Recalls, VA Hospital Missed Recall Notification, Drip Device Dumped All Morphine by Medical Quack Patient ExpertHealth Maven Posted Thu 05 Dec 2013 4:23pm The patient was receiving morphine as part of his cancer treatment and the nurse hooked him up to a morphine drip for pain.  The Infusomat device from B. Braun was the device that malfunctioned and dispensed not a drip but the entire contents of the bag and he received 10 times the amount of what he was supposed to have had.  The device has mis ... Read on »
Class I Medical Device Recall: B. Braun addEASE Binary Connector by Health & Human Services Posted Tue 30 Nov 2010 12:00am Recall Class: Class I Date Recall Initiated: June 24, 2010 Product: addEASE Binary Connectors Catalog numbers N7990 and N7933 Manufactured and distributed from April 4, 2004 to June 4, 2010 Use: The addEASE is used to transfer fluid between a partial additive bag (PAB) and a drug vial. Recalling Firm: ... Read on »
BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall by FDA Posted Wed 15 Sep 2010 4:15pm [Posted 09/15/2010] AUDIENCE: Risk Manager, Emergency Medicine ISSUE: Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection c ... Read on »
Westmed, Inc. Issues Nationwide Recall of BagEasy Manual Resuscitation Devices by FDA Posted Wed 15 Sep 2010 12:46pm FOR IMMEDIATE RELEASE -- September 14, 2010 - Westmed, Inc., Tucson, AZ, is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The select lots listed below of the BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconne ... Read on »
Class I Medical Device Recall: Hospira Intravascular Administration Sets by FDA Posted Wed 14 Aug 2013 12:00am It was discovered that there was a potential for the piercing pin on certain ISO-compliant Hospira blood sets to puncture the outer wall of the non-ISO-compliant blood bags during insertion of the pin into the blood bag. Read on »
Federal Register: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Draft Gui by Health & Human Services Posted Wed 25 Jun 2014 4:00am The FDA is announcing the availability of the draft guidance entitled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices." FDA is issuing this document to inform manufacturers, distributors, and other... Read on »
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Draft Guidance for Indust by Health & Human Services Posted Fri 20 Jun 2014 4:00am The FDA recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical... Read on »