FDA Device Recall Z-0561-2024

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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 / serial / GTIN: (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: 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.

Recall record

Recall number: Z-0561-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
Recall initiated: 2023-10-16
Classified by FDA Center: 2023-12-22
FDA published: 2024-01-03
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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