Medline Industries, LP issues a voluntary nationwide recall of various lots of tracheostomy care and cleaning trays
By Medline Newsroom Staff | December 20, 2023
Northfield, Ill., Dec. 20, 2023 – Medline Industries, LP announced a voluntary nationwide recall on October 10, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture tubing during use and/or cause user injury during handling. In addition, complaints describe bristles of the tracheostomy brush detaching before and potentially during use. If bristles reach a patient’s airway, they may cause unexplained increases in sputum or pulmonary secretions, signs of infection, or difficulty breathing. If a patient exposed to the brush experiences any of these signs or symptoms, they should seek medical attention promptly. To date, Medline Industries, LP has received one adverse event associated with this product.
Tracheostomy Care Trays are medical devices intended to be used for the care and maintenance of a stoma site. These trays may be used in various healthcare environments including acute care settings, such as hospitals, and long-term care settings such as skilled nursing facilities. The tracheostomy brush component is used to clean tracheostomy tubing and cannulas. Tracheostomy cannulas should always be rinsed following brush cleaning. This component is packaged within Tracheostomy Care and Cleaning Trays, which contain multiple components packaged together.
The voluntary recall includes the following item numbers and lot numbers, distributed nationwide from March 21, 2022, through October 10, 2023. Affected product(s) can be identified by the lot number indicated on the medical device packaging.
| Item Number | Item Description | UDI/GTIN Number | Lot Number |
| DYND40580 | TRAY, TRACH,14FR SUCTION CATH, WHISTLE TIP | UDI: 10080196032761 | 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, 6052307012 |
| DYND4061030 | TRAY, TRACH, BASIC, PIPE CLEANERS | UDI: 10080196032877 | 6052209025, 6052209026, 6052210016, 6052210031, 6052210032, 6052211034, 6052212009, 6052212010, 6052212021, 6052212022, 6052212015, 6052301017, 6052306014, 6052306015, 6052306014, 6052306015, 6052307011, 6052307012, 6052307022, 6052307023, 6052307026, 6052308001, 6052308002, 6052308003, 6052308004, 6052309001, 6052309003, 6052309002 |
| CC3T4691A | BASIC TRACHEOSTOMY CARE KIT | UDI: 10080196503391 | 6052204005, 6052204010, 6052204011, 6052205021, 6052205022, 6052205023, 6052205024, 6052206021, 6052207009, 6052207013, 6052207014, 6052207015, 6052207030, 6052208009, 6052208010, 6052208021, 6052208022, 6052209026, 6052209038, 6052210008, 6052210015, 6052210016, 6052210032, 6052211021, 6052302012, 6052302013, 6052306004, 6052306014, 6052306015, 6052306017, 6052307012, 6052307022, 6052307023, 6052308001, 6052308002, 6052308003, 6052309002, 6052309001, 6052309003 |
| CC4681A | TRACHEOSTOMY CARE KIT W/FORCEP | UDI: 10080196503407 | 6052203022, 6052205022, 6052205023, 6052205024, 6052205028, 6052206010, 6052206011, 6052206021, 6052207015, 6052208016, 6052208040, 6052209009, 6052209026, 6052209038, 6052210012, 6052210016, 6052301015, 6052301016, 6052301017, 6052302012, 6052302013, 6052302028, 6052302029, 6052304024, 6052305020, 6052306004, 6052306014, 6052306015, 6052307011, 6052307012, 6052309002, 6052309001, 6052309003 |
| CC3T3030A | MINI TRACHEOSTOMY CARE KIT | UDI: 10080196503384 | 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, 6052308003, 6052309001 |
| DYND40622 | TRAY, TRACH, MINI, NO GLOVES, NONSTERILE | UDI: 10080196032914 | 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, 6052307022, 6052308001, 6052308002, 6052309002, 6052309001, 6052309003 |
| EDUC1025 | NURSE KIT | GTIN: 40195327196647 | 22JDB315, 22HDC340 |
| EDUC05038B | NURSING SKILLS KIT | GTIN: 40195327019878 | 22IDA181, 22FDB543, 22ADB550 |
| EDUC05056A | NURSING TOTE KIT | GTIN: 40195327153695 | 22HDC201, 22HDA420 |
Medline Industries, LP is implementing corrective and preventative actions. Medline Industries, LP notified its distributors and consumers by First Class Mail and email on October 16, 2023, and instructed consumers to destroy and dispose of any affected product per local and state regulations. No product is to be returned to Medline Industries, LP Any consumers or distributors that have product that is being recalled should stop using the product and contact Medline Industries, LP
Consumers with questions regarding this recall can contact Medline Industries, LP. by phone at 866-359-1704 or recalls@medline.com Monday through Friday between the hours of 8 a.m. and 5 p.m. CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this medical device.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
- Online at fda.gov/medwatch/report.htm
- Call FDA 1-800-FDA-1088
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Medline Newsroom Staff
Medline Newsroom Staff
Medline's newsroom staff researches and reports on the latest news and trends in healthcare.
