FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience IV Start Kits recalled for potential sterility breach in applicators

Nationwide distributionMedical devices

What this means

Medline's IV Start Convenience Kits contain sterile applicators (BD ChloraPrep Clear and FREPP Clear) with wrinkles in the paper packaging that may compromise the sterile barrier. If the seal is breached, patients could be exposed to microbial contamination during IV insertion or blood draws.

Check if your facility has any of the affected Medline kit model numbers (CDS860014P, DYKM1000B, DYKM2187, DYKM2187A, DYNDH1909A, or DYNDV1615I).
Do not use kits from the affected lot numbers listed in the recall notice.
Contact Medline or your supplier for replacement kits.
Review patient records if affected kits were used and report any infections to your healthcare provider or infection control team.

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

US Nationwide distribution.

Affected count

22736 Kits

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A; 6) IV START W/EXT SET KIT, Model Number: DYNDV1615I

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3056-2026

More Medline recalls

FDA-Device2026-09-09
Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
FDA-Device2026-09-09
Medline Convenience Kits recalled for sterility packaging breach risk
FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
FDA-Device2026-09-09
Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk

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