Food, drugs, devices › Trinity Sterile, Inc.
Device recall: Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM4606
Trinity Sterile, Inc. (Salisbury, MD) initiated this device recall on 13 Dec 2024; FDA lists 5 product records under event 96068, classified Class II.
FDA defines Class II as 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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Trinity Sterile, Inc. has 3 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Trinity Sterile, Inc., Salisbury, MD.
Reason for recall
"Potential for hole in package compromising sterility of the medical kit."
Distribution
"US Nationwide distribution in the states of MD, PA, TN and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1012-2025 | 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 | 1,980 units | Class II | Ongoing | 29 Jan 2025 |
| Z-1013-2025 | Brand 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: No | 1,980 units | Class II | Ongoing | 29 Jan 2025 |
| Z-1014-2025 | Brand 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: No | 3,960 units | Class II | Ongoing | 29 Jan 2025 |
| Z-1015-2025 | Brand 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: No | 5,940 units | Class II | Ongoing | 29 Jan 2025 |
| Z-1016-2025 | 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 | 280 units | Class II | Ongoing | 29 Jan 2025 |
Context
Other enforcement events for Trinity Sterile, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jun 2022 | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | Device | Class II | 4 |
| 23 Feb 2021 | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter mainte | Device | Class II | 1 |
All 3 events for Trinity Sterile, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for hole in package compromising sterility of the medical kit."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of MD, PA, TN and TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.