Medline IVS Blood Culture Kits Recalled for Sterility Breach
Medline is recalling 17,750 IVS Blood Culture Kits nationwide due to potential packaging defects that may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a risk of harm (microbial contamination and potential infection) without reporting specific illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 17,750 IVS Blood Culture Kits (Model Numbers DYNDH1920 and DYNDH1920A) distributed nationwide in the United States. The recall involves specific lots identified by UDI-DI and lot numbers 2023111390, 2023121890, and 2025022790.
The recall was initiated because the kits contain BD ChloraPrep Clear and FREPP Clear applicators with a potential breach of sterility in the packaging. Wrinkles in the paper lidding may extend to the seal area, potentially compromising the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Users should check their inventory for the affected model numbers and lot numbers and stop using these kits if they match the recalled items.
The recalled product
- Product
- Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A
- Manufacturer
- Medline Industries, LP
- Affected units
- 17,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 1) DYNDH1920
- UDI-DI: 10653160366317(each)
- 00653160366310(case)
- Lot Number: 2023111390
- 2) DYNDH1920
- Lot Number: 2023121890
- 3) DYNDH1920A
- UDI-DI: 10653160385943(each)
- 00653160385946(case)
- Lot Number: 2025022790
Distribution
Distributed nationwide across the United States.
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