On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers.
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.
Sakura Finetek USA
This Lot has variations in melting temperature.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Maquet Medical Systems USA
Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
Philips Healthcare
If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Several complaints were received for the metal support tube missing from the cholangiogram catheter.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).