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Medline Convenience Kits containing BD ChloraPrep Clear -… recallZ-3068-2026 · Medline Industries, LP · initiated Jul 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Firm began notifying consignees on 7/20/2026 via First-Class Mail and email. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.

Recall details

Recall number
Z-3068-2026
Status
Open, Classified
Initiated by the company
Jul 20, 2026
Posted by the FDA
Aug 31, 2026
Recalling firm
Medline Industries, LP
Quantity
222,653 total
Product code
OEZ
Distribution
US Nationwide distribution.

Product description

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB

Code information (models, lots, serial numbers)

CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99561).

Sources and updates

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