Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.

Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information: Pack #CDS981759C - Lot numbers 24ADA460, exp. 7/31/2025; 23KDB724, exp. 7/31/2025; 23JDA205, exp. 10/31/2025; 23IDA683, exp. 11/30/2025; and 23EDA124, exp. 5/31/2025; UDI-DI each-10888277524002 and UDI-DI case-5/31/2025.

Distribution pattern: US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.