FDA Medical devices recall ·
IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL &… recall
- Recall number
- Z-1012-2025
- Date
- (initiated December 13, 2024)
- Company / brand
- Trinity Sterile, Inc.
201 Kiley Dr, Salisbury, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,980 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Potential for hole in package compromising sterility of the medical kit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No IM46062, UDI-DI 10853155008769, Lot Number 600022
Distribution
US Nationwide distribution in the states of MD, PA, TN and TX.
States: Maryland Pennsylvania Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1012-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.