Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Lack of assurance of sterility by manufacturer
The warming catheter was manufactured with the inlet and outlet tubes switched.
Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.
Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.
Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.
Faulty tubing does not prime machine as intended.
Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.
Separation from Bushing: The breathing bag may separate from the bushing during use.