MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITI

Hazard

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.

Details from the source

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: 822 units Lot/code info: 1) REF DYNDA1359A: UDI/DI 10195327417734 (EA) 40195327417735 (CS), Lot Numbers: 23KBW508; 2) REF DYNDA1360B: UDI/DI 10889942903863 (EA) 40889942903864 (CS), Lot Numbers: 23KBB406; 3) REF DYNDC1311C: UDI/DI 10080196151561 (EA) 40080196151562 (CS), Lot Numbers: 23KBX338; 4) REF DYNDC3185: UDI/DI 10195327034108 (EA) 40195327034109 (CS), Lot Numbers: 23KBX632; 5) REF EDUC05015A: UDI/DI 10193489849035 (EA) 40193489849036 (CS), Lot Numbers: 23LDA746, 23LDA814, 23LDA218; 6) REF EDUC1024A: UDI/DI 10195327493165 (EA) 40195327493166 (CS), Lot Numbers: 23LDA281, 23KDA001.

UPC codes

10195327417734, 40195327417735, 10889942903863, 40889942903864, 10080196151561, 40080196151562, 10195327034108, 40195327034109, 10193489849035, 40193489849036, 10195327493165, 40195327493166

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.