Device product
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) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A.
Z-1709-2025
Product summary
- Event
- Event 96630
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 822 units
- Official record key
device-enforcement:Z-1709-2025
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Derived failure modes
-
Unknown
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.