FDAFebruary 23, 2021device
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
What to do
FDA enforcement status: Terminated
Brands named
trinity steriletrinity
UPCs
00841767107942
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.2025-07-22
- FDASodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-502025-02-10
- FDABrand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No2024-12-13
- FDABrand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No2024-12-13
- FDABrand 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: No2024-12-13
- FDABrand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No2024-12-13
- FDABrand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No2024-12-13
- FDATrinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 8029920010092024-11-06
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