Baxter—MiniCaps with Povidone-Iodine Solution: Sponge May Be Separated, Partially Protruding, or Missing
January 21, 2015 | Strategic Insights for Health System
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at firstname.lastname@example.org.
In a January 6, 2015, Important Product Information letter submitted by an ECRI Institute member hospital, Baxter states that it has received reports of the sponge on the caps below fully separating from the cap, partially protruding from the cap, or being neither present inside the cap nor inside the pouch (for examples of each of these possible problems, see the images in the Important Product Information letter). Baxter also states that use of the caps below with separated or missing sponges may compromise the ability of the cap to provide a sterile barrier protection at the end of the transfer when the transfer set is not connected to the patient line of the automated peritoneal dialysis (APD) cassette or continuous ambulatory peritoneal dialysis (CAPD) twin bag setups, potentially increasing the risk of peritonitis. Baxter further states that use of the above caps with sponges partially protruding from the caps may encourage nonaseptic techniques, such as inadvertently touching the sponge to reposition it inside the cap, potentially increasing the risk of peritonitis.