Medical Devices Recalls

Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.

Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Product sterility is not assured

NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.

Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.

Product sterility is not assured

Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.

NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

Product sterility is not assured

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an

Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.