Medline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns
Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I medical device recall meets the minimum severity threshold of 4 (Severe). Although no illnesses have been reported, potential sterility failure in irrigation solutions poses a direct infection risk in tracheostomy care.
Plain-English summary
Medline Industries, LP is recalling specific lots of tracheostomy care kits and trays: TRACH CARE KIT (REF DYND40589 and DYNDA3004), TRACHEOSTOMY CARE TRAY (REF DYND40650), and TRAY, TRACH, W/PCLNR, 14FR CATH N (REF DYND40594). These products contain component irrigation solutions (0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe) manufactured by Nurse Assist. A total of 991,744 units have been distributed.
The recall was initiated because the component irrigation solutions may lack sterility. Non-sterile solutions could contaminate the tracheostomy care procedure and potentially harm patients.
These kits and trays were distributed throughout the United States, including Puerto Rico, and internationally to Canada, the United Arab Emirates, and Panama. Consumers and medical facilities using these products should stop using them immediately and contact their supplier for return or replacement instructions. Specific lot numbers are listed in the FDA recall notice by product reference number.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF DYND40589
- UDI/DI 40080196032823 (case)
- 10080196032822
- (unit)
- Lot Numbers: 2022032590
- 2022033190
- 2022040190
- 2022040790
- 2022041490
- 2022041890
- 2022050690
- 2022052090
- 2022060990
- 2022062990
- 2022071390
- 2022063090
- 2022071590
- 2022071290
- 2022071890
- 2022080290
Distribution
Distributed nationwide across the United States.
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