It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Reason for recall: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening. Distribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada. Quantity: 5200 units Lot/code info: 1) REF DYNDA1412A: UDI/DI 10193489693423 (EA) 40193489693424 (CS), Lot Numbers: 23KBH040; 2) REF DYNDL1263A: UDI/DI 10884389347126 (EA) 40884389347127 (CS), Lot Numbers: 23KBD401.
10193489693423, 40193489693424, 10884389347126, 40884389347127
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.