Moderate riskFDA DeviceClass II

Medline IV Start Kits recalled for potentially contaminated ChloraPrep applicators

Medline Convenience Kits containing BD ChloraPrep Clear applicators from specific lots may have open or incomplete seals on the applicator packaging. Use of a potentially contaminated applicator during IV insertion or lab draws could lead to skin, soft tissue, or systemic infection.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if your kit matches one of the affected lot numbers listed in the recall notice.
  2. Do not use applicators from affected lots.
  3. Contact your healthcare facility or Medline to confirm whether your kits are affected and obtain replacement kits.
  4. If you have already used an applicator from an affected lot and develop signs of infection at the insertion site, contact your healthcare provider.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684
Sold in
Nationwide
Made for
Adults

This recall covers 13 products — see all of them.

Details

Units affected
222,653 total
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-3071-2026

In the FDA's words

Description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684 Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. CDS860014Q UDI-DI 10198459629822 Lots 26ABR359 26BBP789 26CBL940 26DBK987 26FBK255 26FBK816 DYKM1000B UDI-DI 10889942508143 Lots 24KMD782 24LMH404 25AMD765 25BMD744 CDS860014P UDI-DI 10888277797819 Lots 24IBA155 24JBY045 24LBM014 25HBR509 25JBX951 DYNDV2684 UDI-DI 10198459185465 Lot 24LBP243 Distribution: US Nationwide distribution. Affected quantity: 222,653 total
Hazard
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

13 products in this recall

Medline convenience kits recalled for ChloraPrep applicator seal defect

Medline is recalling 13 convenience kits that contain BD ChloraPrep Clear 1mL applicators from specific lots. The applicator packaging may have an open or incomplete seal, so the applicator could be contaminated. Contaminated applicators can cause skin or soft tissue infections, or more serious infections, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

Updates since first reported

  • Oct 6, 2026Hazard description updated

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