Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster
Summary
The FDA issued a Class I for Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 by MEDLINE INDUSTRIES, LP - Northfield. Reason: The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, .
Details
Source
Device Recall
External ID
Z-0561-2024
Action Date
2024-01-03
Status
Ongoing
Category
device
Product Description
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medline Tracheostomy Care Kit with Glove, REF CC4681A, Sterile; (5) Medline Mini Tracheostomy Care Kit, REF CC3T3030A, Sterile; and (6) Medline Mini Tracheostomy Care Kit, REF DYND40622, Non-sterile.
Lot/Code Info: (1) DYND40580 - UDI 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, and 6052307012. (2) DYND4061030 - UDI 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, and 6052309002. (3) CC3T4691A - UDI 10080196503391, lot numbers: 6052302012, 6052302013, 6052306004, 6052306014, 6052306015, 6052306017, 6052307012, 6052307022, 6052307023, 6052308002, and 6052308003. (4) CC4681A - UDI 10080196503407, lot numbers: 6052301017, 6052302012, 6052302013, 6052302028, 6052302029, 6052304024, 6052305020, 6052306004, 6052306014, 6052306015, 6052307011, and 6052307012. (5) CC3T3030A - UDI 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, and 6052308003. (6) DYND40622 - UDI 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, and 6052307022.
Quantity Affected: 620,735 kits
Reason for Recall
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
Distribution
US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-16
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 94 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0561-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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