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Stability failure at the 20 month for viscosity specification
Product may be packaged with an incorrect instructions for use (IFU) booklet.
Lot is being recalled because some of the kits contain an incorrect guidewire.
The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.
The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
Incorrect units are printed in labeling but not in software.
Failure of foot pedal to activate device
The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
The demand valve is defective and does not function as intended in the 'Conservative Mode'.
Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae
Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.