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Tracheostomy care kits recallZ-0561-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

The recalling firm issued "MEDICAL DEVICE RECALL" letters dated 10/16/2023 via first class mail and email explaining the reason for recall and the required actions that needed to be taken. The actions for consignees to take included checking their stock for the affected item numbers and affected lot numbers which are located within the recall portal; using the link, https://recalls.medline.com, provided in the letter to complete the response form with the quantity of affected product in inventory; and destroy the affected inventory for credit. If the consignee is a distributor who has resold or transferred the product to another company or individual, they are to notify them of this recall and document the amount of product their customer destroyed on their (the distributor) response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-0561-2024
Status
Open, Classified
Initiated by the company
Oct 16, 2023
Posted by the FDA
Dec 22, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
620,735 kits
Product code
OGV
Distribution
US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.

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.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

(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.

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93327).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page