Medical equipment, implants, and diagnostic devices
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
The donor was hemodiluted.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on th
Siemens Healthcare Diagnostics
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
Teleflex Medical
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Teleflex Medical
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Shimadzu Medical Systems
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.
Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water.
Biorep Technologies
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.