Salisbury, MD, United States
Trinity Sterile, Inc. recalls
3 recalls recorded since 2018, most recently on 13 December 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 December 2024
- Reason
- Potential for hole in package compromising sterility of the medical kit.
- Distribution
- US Nationwide distribution in the states of MD, PA, TN and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1015-2025, Z-1012-2025, Z-1014-2025, Z-1013-2025, Z-1016-2025
- 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, 19
- 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 ca
- 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
- 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
- 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. Com
Terminated Class II Medical devices
- Recall started
- 29 June 2022
- Terminated
- 10 May 2024
- Reason
- Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
- Distribution
- US Nationwide distribution in the states of FL, PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1548-2022, Z-1551-2022, Z-1550-2022, Z-1549-2022
- Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
- Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
- Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
- Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
Terminated Class II Medical devices
- Recall started
- 23 February 2021
- Terminated
- 16 February 2023
- Reason
- Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
- Distribution
- US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1468-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.