Z-3068-2026Class II

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

Name: Z-3068-2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Creator: Medline Industries, LP
Published: 2026-07-20
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-07-20 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB on 2026-07-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3068-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-20
Posted: 2026-08-31
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 222,653 total
Distribution: US Nationwide distribution.
Product codes and lots: CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3068-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3067-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3068-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3069-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3070-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3071-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3072-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3073-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3074-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3075-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3076-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3077-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3078-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3079-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)