Dressing Change Tray Recalled Due to Potential Package Sterility Compromise
Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with potential sterility compromise due to package breach. No reported illnesses or injuries; the hazard is theoretical, so the score is capped at 3 per the rubric.
Plain-English summary
Trinity Sterile, Inc. is recalling the Dressing Change Tray CS/20 (Model TM6180CP, Lot 600032) due to a potential hole in the package that may compromise the sterility of the medical kit.
The recalled product is a dressing change tray sold in cases of 20 units. A total of 280 units across 50 cases have been affected. These units were distributed to healthcare facilities and providers in Maryland, Pennsylvania, Tennessee, and Texas.
Consumers should not use the affected product and should contact their healthcare provider or the manufacturer for guidance on replacement or proper disposal.
The recalled product
- Product
- Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
- Manufacturer
- Trinity Sterile, Inc.
- Affected units
- 280
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 (3)
- Model No TM6180CP
- UDI-DI 58500425700020
- Lot Number 600032
Distribution
Part of a larger recall action
This product is one of 5 recalled by Trinity Sterile, Inc. 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Trinity Sterile, Inc.
See all →- HighWolf-Pak Dressing Change Kits Recalled Due to Package Defects
FDA (Devices) · 2025-01-29
- HighDressing Change Kit Recalled Due to Package Integrity Concern
FDA (Devices) · 2025-01-29
- HighDressing Change Kits Recalled for Potential Package Sterility Compromise
FDA (Devices) · 2025-01-29
- HighDressing change kits recalled due to packaging defect compromising sterility
FDA (Devices) · 2025-01-29
- HighMedical Dressing Kit Recalled for Mislabeled Latex Content
FDA (Devices) · 2022-08-24
Same hazard · package breach
See all →- SevereCareFusion Recalls Non-Sterile ChloraPrep Solution Due to Microbial Contamination Risk
FDA (Drugs) · 2021-03-03
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