Highlighted articles include:
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination
Customers advised not to use Prep Pads in black starter kits for Forteo [teriparatide (rDNA origin) injection]...
Millar Mikro-Tip Angiographic Catheter: Recall
Certain affected models found to contain particulate debris within the catheter lumen...
H & P Industries Povidine Iodine Prep Pads: Recall
Testing showed the presence of Elizabethkingia meningoseptica which could lead to life-threatening infections, especially in at risk populations...
Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test and, AccuProbe Mycobacterium Avium Complex Culture Identification Test: Recall
Affected kits may contain tube components that are partially empty or empty of solution, this may lead to false-negative results...
'Smart' Infusion Pumps are Selectively Intelligent
Smart pumps can't prevent all programming and administration errors...
Roche Insulin Delivery Systems announces recall of ACCU-CHEK FlexLink Plus infusion sets
Potential for under delivery of insulin due to a kinked/bent cannula when inserting the ACCU-CHEK FlexLink Plus infusion set...
Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays
The potential exists for leakage and possible loss of sterility due to leak in the plunger Luer...
Davol XenMatrix Surgical Graft: Class I Recall
Several lots of XenMatrix Surgical Graft have been found to have elevated endotoxin levels...
ConMed Tru-Link Neotrode Recall
Certain devices have a loose wire attachment that may lead to intermittent or poor signal quality...
Home Use Devices - Featured Case Studies
FDA's Home Use Device website provides resources and safety information about medical products used in the home environment...
MedSun's KidNet - A Model for Patient Safety
KidNet is a specialty subnetwork of FDA's Medical Product Safety Network (MedSun). It focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric patient populations, especially those occurring in neonatal and pediatric intensive care units (NICUs and PICUs).
You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).
The content on the Homepage has been updated to reflect this month's Newsletter items. This information can be viewed by clicking here.
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