Medline Convenience Kits Recalled for Potential Sterility Breach
Medline is recalling 434,595 convenience kits nationwide due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
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 confirmed 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 434,595 units of various medical convenience kits, including IV start kits, blood culture kits, and emergency trays, distributed nationwide in the United States. The recall is due to a potential breach of sterility in the packaging of specific components, namely BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators.
The defect involves wrinkles in the paper lidding that 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. The source text notes that potential health consequences range from no injury to localized infection, or less commonly, more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening.
Healthcare facilities and users should check their inventory for the affected catalog numbers and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Medline or the distributor for replacement or refund, in accordance with the recall instructions.
The recalled product
- Product
- Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 434,595
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 (20)
- 1) DYNDV2520
- UDI-DI: 10653160384045(each)
- 00653160384048(case)
- Lot Number: 2023122690
- 2) DYNDV2520
- Lot Number: 2024020790
- 3) DYNDV2520
- Lot Number: 2024032790
- 4) DYNDV2520
- Lot Number: 2024052390
- 5) DYNDV2520
- Lot Number: 2024071190
- 6) DYNDV2520
- Lot Number: 2024081490
- 7) DYNDV2520
- Lot Number: 2024101090
- 8) DYNDV2520
- Lot Number: 2024111990
- 9) DYNDH1983A
- UDI-DI: 10653160388920(each)
Distribution
Distributed nationwide across the United States.
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