Dressing change kits recalled due to packaging defect compromising sterility
Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.
What this means for you
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: This is a Class II medical device recall involving a potential packaging defect that could compromise sterility. While no illnesses or injuries have been reported, the potential loss of sterility in a wound care product presents a theoretical risk of patient harm, fitting the 'High' category per the severity rubric.
Plain-English summary
Trinity Sterile, Inc. is recalling dressing change kits (IMed Products Dressing Change Kit with ChloraPrep 3mL & HaloGUARD, Model IM46062, Lot #600022) because of a potential defect in the packaging that could create holes and compromise the sterility of the kit. The recall affects 1,980 units that were distributed to states including Maryland, Pennsylvania, Tennessee, and Texas.
Sterile medical dressing kits must maintain package integrity to preserve the sterility of the contents. A hole in the package could allow bacteria or other contaminants to enter, potentially rendering the product no longer sterile.
Anyone who has received these kits should discontinue use and contact Trinity Sterile, Inc. for instructions on replacement or proper disposal.
The recalled product
- Product
- Brand 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: No
- Manufacturer
- Trinity Sterile, Inc.
- Hazard
- sterility-compromise
- package-defect
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 IM46062
- UDI-DI 10853155008769
- Lot Number 600022
Distribution
Distributed nationwide across the United States.
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