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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Tracheostomy Care and Nursing Kits Recalled for Sharp Edges and Detaching Bristles

Agency Publication Date: December 22, 2023
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Summary

Medline Industries is recalling 621,457 tracheostomy care kits and nursing skills trays because the included cleaning brush has a sharp metal edge at the tip. There have also been reports of the brush bristles detaching from the wire before or during use. These kits, which include brand names like Medline Tracheostomy Clean and Care Tray and Medline Basic Tracheostomy Care Kit, were distributed nationwide in the U.S. and to several international locations including Canada, Panama, and the United Arab Emirates. Consumers should immediately identify if they have affected kits by checking the product reference (REF) and lot numbers on the packaging.

Risk

The sharp tip of the tracheostomy brush can puncture medical tubing or cause internal injuries to patients and healthcare providers during use. Additionally, if the bristles detach, they may be left behind in the airway or the tracheostomy tube, potentially causing choking, respiratory distress, or infection.

What You Should Do

  1. Locate the packaging for your tracheostomy care or nursing kit and check the Product Reference (REF) or SKU number and Lot Number against the affected list. Affected REF numbers include DYND40580, DYND4061030, CC3T4691A, CC4681A, CC3T3030A, DYND40622, EDUC05038B, EDUC1025, and EDUC5056A.
  2. Check for specific lot numbers such as 6052203006, 6052307012, 22IDA181, 22JDB315, and 22HDA420. A full list of over 100 affected lot numbers is associated with these kits; compare your package labeling to the specific identifiers provided in the product details.
  3. Immediately stop using any kits that match the affected REF/SKU and Lot numbers to prevent injury or equipment damage.
  4. Contact your healthcare provider or Medline Industries directly at 1-800-633-5463 to report any issues and for further instructions on returning or replacing the affected kits.
  5. For nursing students or educators using the 'For Training Purposes Only' kits (SKUs EDUC05038B, EDUC1025, EDUC5056A), ensure these are removed from training supplies and not used on simulation mannequins or for human use.
  6. For additional information or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Healthcare provider or manufacturer consultation

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

Affected Products

Product: Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter
Model / REF:
DYND40580
UPC Codes:
10080196032761
Lot Numbers:
6052203006
6052203022
6052204005
6052204010
6052205024
6052206003
6052206010
6052206011
6052206020
6052206021
6052207009
6052207013
6052207014
6052207015
6052208021
6052208022
6052209009
6052209025
6052209026
6052212023
6052301031
6052303011
6052303013
6052303014
6052304020
6052305007
6052305019
6052306004
6052306014
6052306015
6052305026
6052306026
6052306032
6052307006
6052307011
6052307012
Product: Medline Tracheostomy Clean and Care Tray
Model / REF:
DYND4061030
UPC Codes:
10080196032877
Lot Numbers:
6052209025
6052209026
6052210016
6052210031
6052210032
6052211034
6052212009
6052212010
6052212021
6052212022
6052212015
6052301017
6052306014
6052306015
6052307011
6052307012
6052307022
6052307023
6052307026
6052308001
6052308003
6052309001
6052309003
6052309002
Product: Medline Basic Tracheostomy Care Kit
Model / REF:
CC3T4691A
UPC Codes:
10080196503391
Lot Numbers:
6052302012
6052302013
6052306004
6052306014
6052306015
6052306017
6052307012
6052307022
6052307023
6052308002
6052308003
Product: Medline Tracheostomy Care Kit with Glove
Model / REF:
CC4681A
UPC Codes:
10080196503407
Lot Numbers:
6052301017
6052302012
6052302013
6052302028
6052302029
6052304024
6052305020
6052306004
6052306014
6052306015
6052307011
6052307012
Product: Medline Mini Tracheostomy Care Kit (Sterile)
Model / REF:
CC3T3030A
UPC Codes:
10080196503384
Lot Numbers:
6052204010
6052204011
6052205021
6052205022
6052205023
6052205024
6052205028
6052206003
6052206010
6052206011
6052210015
6052210016
6052210031
6052210032
6052212010
6052212023
6052301015
6052301016
6052301017
6052301029
6052302012
6052302013
6052303011
6052303012
6052303013
6052303014
6052304019
6052304020
6052305007
6052305020
6052306004
6052306014
6052306015
6052307011
6052307012
6052307022
6052307023
6052308001
6052308002
6052308003
Product: Medline Mini Tracheostomy Care Kit (Non-sterile)
Model / REF:
DYND40622
UPC Codes:
10080196032914
Lot Numbers:
6052203006
6052204005
6052204010
6052205023
6052205028
6052206003
6052206010
6052207009
6052207030
6052208009
6052208021
6052208040
6052209027
6052209025
6052210008
6052210031
6052210032
6052212009
6052212021
6052212023
6052301016
6052302013
6052302028
6052303012
6052303014
6052305018
6052305019
6052305020
6052306004
6052306014
6052306015
6052306017
6052307022
Product: Nursing Skills Kit (Training Purposes Only)
Model / REF:
EDUC05038B
UPC Codes:
40195327019878
Lot Numbers:
22IDA181
22FDB543
22ADB550
Product: Nurse Kit (Training Purposes Only)
Model / REF:
EDUC1025
UPC Codes:
40195327196647
Lot Numbers:
22JDB315
22HDC340
Product: Nursing Tote Kit (Training Purposes Only)
Model / REF:
EDUC5056A
UPC Codes:
40195327153695
Lot Numbers:
22HDC201
22HDA420

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93327
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; authorized medical supply distributors; healthcare facilities
Manufactured In: United States
Units Affected: 3 products (620,735 kits; 172 kits; 550 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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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 · FDA Press Release · 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.