🏥 Medical Devices • 7,015 recalls
False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/07/2015 to include additional catheters.
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
Report by a customer of an open package seal.
Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
Richard Wolf Medical Instruments
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Richard Wolf Medical Instruments
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.
Richard Wolf Medical Instruments
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Instrumentation Laboratory
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
Baxter Corporation Englewood
All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
Smith & Nephew, Inc., Endoscopy Div.
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Smith & Nephew, Inc., Endoscopy Div.
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Reports related to ingress of air into the manifold.
All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.
On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.