Medline Convenience Kits Recalled for Potential Sterility Breach
Medline is recalling 104 convenience kits 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that potential health consequences include hospitalization, which aligns with the rubric criterion for FDA Class II recalls with hospitalization reports.
Plain-English summary
Medline Industries, LP is recalling 104 convenience kits, specifically the Drawer 9 Cricothyrotomy Kit (Model ACC010741) and the Kit Anesthesia L&D A-Line Set (Model DYKMBNDL199A). The recall involves specific lots of these kits distributed nationwide in the United States.
The recall is issued because the kits contain BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators that have 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 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, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Users should stop using the affected kits and contact Medline for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 104
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) ACC010741
- UDI-DI: 10195327515515(each)
- 40195327515516(case)
- Lot Number: 23KDB215
- 2) DYKMBNDL199A
- UDI-DI: 10193489848540(each)
- 40193489848541(case)
- Lot Number: 24LBT847
- 3) DYKMBNDL199A
- Lot Number: 24LBB138
Distribution
Distributed nationwide across the United States.
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