Medline Tracheostomy Care Trays Recalled for Sterility Issues
Medline Industries is recalling 528 latex-free tracheostomy care trays due to potential sterility failure in component irrigation solutions. Non-sterile solutions pose infection risk.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls score at minimum 4. Although no illnesses or deaths have been reported, non-sterile irrigation solutions used in invasive tracheostomy care procedures pose significant infection risk.
Plain-English summary
Medline Industries, LP is recalling certain Centurion latex-free tracheostomy care trays (Reference TC7170) that were distributed nationwide. The recall affects 528 units.
The recall was initiated due to potential lack of sterility in component solutions supplied by Nurse Assist: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Non-sterile solutions could result in serious infection for patients.
The affected product was distributed in the United States nationwide, including Puerto Rico, and internationally in Canada, UAE, and Panama. Affected lot numbers are 2022042790, 2022121290, 2023031790, 2023042490, and 2023092190.
The recalled product
- Product
- Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 528
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 (8)
- REF TC7170
- UDI/DI 50653160043629 (case)
- 00653160043624 (unit)
- Lot Numbers: 2022042790
- 2022121290
- 2023031790
- 2023042490
- 2023092190
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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