FDA Device recall Z-0561-2024
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile
- FDA Device
- Class I
- ongoing
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class I recall of Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile by Medline Industries Northfield, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0561-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-16 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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.
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, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
Identifiers
| code_info | (1) DYND40580 - UDI 10080196032761, lot numbers: 6052203006, 6052203022, 6052204005, 6052204010, 6052205024, 6052206003…(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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.