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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/Diagnostic Equipment

MEDLINE INDUSTRIES, LP - Northfield: Blood Culture Collection Kits Recalled for Premature Component Expiration

Agency Publication Date: November 16, 2023
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Summary

Medline Industries is recalling approximately 13,270 blood culture collection kits across five different models because certain components inside the kits have expired before the overall kit expiration date listed on the package insert. Using expired medical components can compromise the integrity of blood samples or lead to inaccurate diagnostic results. These kits were distributed nationwide, including in California, and were manufactured in the United States. You should contact your healthcare provider or Medline Industries to determine if your specific kits are affected and to receive instructions on replacement or disposal.

Risk

The use of expired components within these diagnostic kits may lead to compromised sterile environments or degraded reagents, potentially causing false-negative or false-positive blood culture results. Inaccurate results can delay proper treatment for serious blood infections or lead to unnecessary antibiotic therapy.

What You Should Do

  1. Identify your kit by checking the product name and reference number on the packaging: ADLT BLOOD CULTURE COLLECT KIT (REF DYNDH1245), PERIPHERAL BLOOD CULTURE DRAW (REF DYNDH1561), CENTRAL LINE BLOOD CULTURE DRA (REF DYNDH1562), 24 BLOOD CULTURE KIT (REF DYNDH1632), or BLOOD CULTURE KIT (REF DYNDH1647B).
  2. Check your kit's case or unit for the following Lot Numbers: 23EMI373, 23EMF712, 23DMF155, 23CMH026, 23EMF711, 23CMH027, 23DMF156, 23CMH030, 23CMD955, 23EMF710, 23DMF154, 23DMA779, 23CMH028, or 23CMD954.
  3. Verify the UDI/DI codes located on the case or individual unit: 40889942604723, 10889942604722, 40193489402811, 10193489402810, 40193489402446, 10193489402445, 40193489916141, 10193489916140, 40195327267002, or 10195327267001.
  4. Immediately stop using any kits identified as part of the affected lots and isolate them from your active inventory.
  5. Contact Medline Industries, LP or your healthcare provider for specific instructions regarding the return or disposal of these kits and to arrange for potential replacements.
  6. For further information or additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions for affected kits

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Model / REF:
DYNDH1245
UPC Codes:
40889942604723
10889942604722
Lot Numbers:
23EMI373
23EMF712
23DMF155
23CMH026
Product: PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
Model / REF:
DYNDH1561
UPC Codes:
40193489402811
10193489402810
Lot Numbers:
23EMF711
23CMH027
Product: CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
Model / REF:
DYNDH1562
UPC Codes:
40193489402446
10193489402445
Lot Numbers:
23DMF156
23CMH030
23CMD955
Product: 24 BLOOD CULTURE KIT, REF DYNDH1632
Model / REF:
DYNDH1632
UPC Codes:
40193489916141
10193489916140
Lot Numbers:
23EMF710
23DMF154
23DMA779
Product: BLOOD CULTURE KIT, REF DYNDH1647B
Model / REF:
DYNDH1647B
UPC Codes:
40195327267002
10195327267001
Lot Numbers:
23CMH028
23CMD954

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93379
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospital supply distributors; Medline Industries
Manufactured In: United States
Units Affected: 5 products (4850 kits; 1770 kits; 1600 kits; 3160 kits; 1890 kits)
Distributed To: Nationwide

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.

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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.