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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Convenience Kits Recalled for Potential Sterility Breach

Agency Publication Date: July 21, 2025
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Summary

Medline Industries, LP is recalling 16,892 Medline Convenience Kits because they contain 1 mL BD ChloraPrep Clear applicators with potentially open packaging seals. These medical kits, which include Labor Triage, IV Start, Blood Culture, and C-Section Prep kits, were affected by a recall originally initiated by BD due to the packaging defect. Because the seals may be open, the sterility of the applicators cannot be guaranteed, which could lead to infections in patients.

Risk

An open seal on the applicator packaging may compromise its sterility. Using a non-sterile applicator during medical procedures can lead to serious healthcare-acquired infections for the patient.

What You Should Do

  1. This recall affects Medline Convenience Kits containing BD ChloraPrep Clear 1 mL Applicators, including Labor Triage Kits (REF DYKM1564), IV Start Kits (REF CDS860014P), Blood Culture Kits (REF DYNDH1462B, DYNDH1622C, DYNDH1866), and C-Section Prep Kits (REF DYNJ32702B).
  2. Check your inventory for the affected lot numbers and REF codes listed on the packaging, including lots 24EBR566, 24EBR549, 24EBU164, 24FBD281, 24FBK195, 24EBU004, 24EBT285, and 24EBR761.
  3. Stop using the recalled medical kits immediately.
  4. Contact Medline Industries, LP or your distributor directly to arrange for the return, replacement, or correction of the affected convenience kits.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Labor Triage Kit (REF DYKM1564)
Model / REF:
DYKM1564
Lot Numbers:
24EBR566
UDI:
10889942754571
GTIN:
40889942754572

Contains BD ChloraPrep Clear - 1mL Applicator.

Product: Medline IV Start Kit Lab Draw-SH (REF CDS860014P)
Model / REF:
CDS860014P
Lot Numbers:
24EBR549
UDI:
10888277797819
GTIN:
40888277797810

Contains BD ChloraPrep Clear - 1mL Applicator.

Product: Medline Blood Culture Kit (REF DYNDH1462B)
Model / REF:
DYNDH1462B
Lot Numbers:
24EBU164
24FBD281
24FBK195
UDI:
10195327662462
GTIN:
40195327662463

Contains BD ChloraPrep Clear - 1mL Applicator.

Product: Medline Blood Culture Kit (REF DYNDH1622C)
Model / REF:
DYNDH1622C
Lot Numbers:
24EBU004
UDI:
10195327509873
GTIN:
40195327509874

Contains BD ChloraPrep Clear - 1mL Applicator.

Product: Medline Blood Cultr Kt Divrsn Device (REF DYNDH1866)
Model / REF:
DYNDH1866
Lot Numbers:
24EBT285
UDI:
10195327400958
GTIN:
40195327400959

Contains BD ChloraPrep Clear - 1mL Applicator.

Product: Medline C-Section Prep (REF DYNJ32702B)
Model / REF:
DYNJ32702B
Lot Numbers:
24EBR761
UDI:
10193489431070
GTIN:
40193489431071

Contains BD ChloraPrep Clear - 1mL Applicator.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97154
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospitals; Medical facilities; Medical distributors
Manufactured In: United States
Units Affected: 4 products (960 units; 184 units; 15700 units; 48 units)
Distributed To: California, Florida, Pennsylvania, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.