FDAFDA recall Z-3055-2026 · Sep 9, 2026
Medline Industries, LP: Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT recall
Recall found
Product
Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
Reason for recall
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
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 1) ART1295, UDI-DI: 10653160380733(each), 00653160380736(case), Lot Number: 2024092790; 2) ART1295, UDI-DI: 10653160380733(each), 00653160380736(case), Lot Number: 2025042590; 3) ART1295, UDI-DI: 10653160380733(each), 00653160380736(case), Lot Number: 2025070290
- Quantity
- 1840 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-12
Source: openFDA enforcement record Z-3055-2026 · search recall number Z-3055-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.