Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Shippert Medical Technologies
ðĨ Medical Devices âĒ 4,540 recalls
Shippert Medical Technologies
Shippert Medical Technologies
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
There is a potential of fracture, bending or shearing of the driver.
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
There is a potential of fracture, bending or shearing of the driver.
Product mislabeling.
Product mislabeling.
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
The bone screw is shorter than the intended design specification.
2.5 Truliant Fit Trays were mismarked as 3
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110ÂŋF
ulrich medical USA
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110ÂŋF
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110ÂŋF