Medline Arterial Line Insertion Kits Recalled for Sterility Breach
Medline is recalling 1,840 Arterial Line Insertion Kits due to potential 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medline Industries, LP is recalling 1,840 units of the Arterial Line Insertion Kit, Model Number ART1295. The recall affects kits distributed nationwide in the United States. The specific lots involved are 2024092790, 2025042590, and 2025070290.
The recall is due to a potential breach of sterility in the packaging of the BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators included in the kits. Wrinkles in the paper lidding may extend to the seal area, compromising the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences include no injury, 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. Healthcare facilities should stop using the affected kits and contact Medline for instructions on return or disposal.
The recalled product
- Product
- Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,840
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 (8)
- 1) ART1295
- UDI-DI: 10653160380733(each)
- 00653160380736(case)
- Lot Number: 2024092790
- 2) ART1295
- Lot Number: 2025042590
- 3) ART1295
- Lot Number: 2025070290
Distribution
Distributed nationwide across the United States.
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