Medline Convenience Kits, containing BD ChloraPrep Clear -… recallZ-2156-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jun 12, 2025
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-2156-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2025
- Posted by the FDA
- Jul 21, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 48 units
- Product code
- OHM
- Distribution
- Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Product description
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Code information (models, lots, serial numbers)
UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ32702BMedline Industries, Inc. · Cesarean section tray3 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97154).
- Z-2153-2025 · Open, ClassifiedMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
- Z-2154-2025 · Open, ClassifiedMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
- Z-2155-2025 · Open, ClassifiedMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULT…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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