FDA Medical devices recall ·
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator… recall
- Recall number
- Z-2155-2025
- Date
- (initiated June 12, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15700 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) REF DYNDH1462B: UDI/DI 10195327662462 (EA), 40195327662463 (CASE), Lot Numbers: 24EBU164, 24FBD281, 24FBK195; 2) REF DYNDH1622C: UDI/DI 10195327509873 (EA), 40195327509874 (CASE), Lot Numbers: 24EBU004; 3) REF DYNDH1866: UDI/DI 10195327400958 (EA), 40195327400959 (CASE), Lot Numbers: 24EBT285.
Distribution
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
States: California Florida Pennsylvania Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2155-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.