Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A
Published September 9, 2026 · Recall initiated: June 12, 2026
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
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US Nationwide distribution.
- Lot
- 1) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023111390; 2) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023121890; 3) DYNDH1920A, UDI-DI: 10653160385943(each), 00653160385946(case), Lot Number: 2025022790
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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