Z-2156-2025Class II

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF...

Name: Z-2156-2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-06-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-06-12 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B on 2025-06-12. FDA classified it as Class II and gives the reason as "Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2156-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-12
Posted: 2025-07-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Product code: OHM Cesarean Section Tray
Reason for recall: Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Root cause tag: packaging
FDA root cause: Other
Action: On June 12, 2025, firm instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No product is to be returned.
Quantity in commerce: 48 units
Distribution: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Product codes and lots: UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2156-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2153-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2154-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2155-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2156-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21

Product code OHM

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)