FDA Issues Update on Recalled Surgical Kit for Newborns
The FDA has issued on update on Cardinal Health’s recall of its Argyle UVC (umbilical venous catheter) insertion trays for newborns, deeming it a Class 1 recall because of the risk of serious injury or death.
The 7,197 kits covered in the June 16 recall were manufactured between Aug. 13, 2019, and March 20, 2021, and distributed between Aug. 13, 2019, and May 21, 2021.
A scalpel in the kit has a permanent locking feature that will not allow a clinician to unlock it once the safety shield is in the locked position, but the instructions explaining this are missing from the kit, the FDA noted. If the clinician is not aware of the locking feature, it could lead to a delay in the procedure to find a replacement scalpel, the agency said.