CareFusion 303 Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide recall — FDA Z-2825-2020
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose from…
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can…
FDA revocation of the Emergency Use Authorization due to performance issues
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger…
FDA revocation of the Emergency Use Authorization due to performance issues
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
The products were improperly heat treated.
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A…
Sterile introducer sheath set manufactured under one lot with different expiration dates.
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger…
Multiple lots being recalled due to a product design issue
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger…
While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being…
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking…
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image…
Undeclared cashews in the product.
Product contains undeclared hydrolyzed soy protein.
Undeclared cashews in the product.
Undeclared wheat
Undeclared cashews in the product.
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