—#203987

Product

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.

FDA product code: OGV — Tracheostomy Cleaning Tray
Device class: Class 2
Medical specialty: Anesthesiology
Affected 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.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.

Timeline

Recall initiated: 2023-10-16
Posted by FDA: 2023-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.