FDAFDA · Food and drugs·Recall number Z-1709-2025
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.
Published May 7, 2025 · Recall initiated: March 19, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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