CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
Medline Convenience Kits, containing BD ChloraPrep Clear recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience Kits, containing BD ChloraPrep Clear - Applicator, labeled as, distributed nationwide in the US. The recall was initiated on 12 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2156-2025
- FDA event ID
- 97154
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jun 2025
- FDA classified
- 21 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 12 Jun 2025 | Recall initiated by company | |
| 21 Jul 2025 | Classified by FDA | +39 days |
| 30 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Where it was distributed
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Questions about this recall
Is Medline Convenience Kits, containing BD ChloraPrep Clear - Applicator, labeled as recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Convenience Kits, containing BD ChloraPrep Clear - Applicator, labeled as on 12 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-2156-2025.
Why was it 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.
Which lots are affected?
UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761
Where was it sold?
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MEDLINE INDUSTRIES, LP - Northfield
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| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
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Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |