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.
Reason for recall: 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. Distribution: 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. Quantity: 12,588 total sterile kits Lot/code info: Pack #DYNJ56073C - lot numbers 23IDA509, exp. 5/31/2026, and 23DDC159, exp. 11/30/2025, UDI-DI each-10193489441833, UDI-DI case-40193489441834.
10193489441833, 40193489441834
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.