Medical DeviceJan 29, 2025
Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recall — FDA Z-1015-2025
Potential for hole in package compromising sterility of the medical kit.
Class IIFDA: OngoingTrinity Sterile, Inc.
Recall history in this database
Classification mix: Class II: 10.
Medical DeviceJan 29, 2025
IMed Products Dressing Change Kit with ChloraPrep 3mL & HaloGUARD recall — FDA Z-1012-2025
Potential for hole in package compromising sterility of the medical kit.
Class IIFDA: OngoingTrinity Sterile, Inc.
Medical DeviceJan 29, 2025
Wolf-Pak Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step recall — FDA Z-1014-2025
Potential for hole in package compromising sterility of the medical kit.
Class IIFDA: OngoingTrinity Sterile, Inc.
Medical DeviceJan 29, 2025
Wolf-Pak Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 recall — FDA Z-1013-2025
Potential for hole in package compromising sterility of the medical kit.
Class IIFDA: OngoingTrinity Sterile, Inc.
Medical DeviceJan 29, 2025
Tacy Medical, Inc. Dressing Change Tray CS/20 recall — FDA Z-1016-2025
Potential for hole in package compromising sterility of the medical kit.
Class IIFDA: OngoingTrinity Sterile, Inc.
Medical DeviceAug 24, 2022
Trinity Sterile Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 recall — FDA Z-1548-2022
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
Class IIFDA: TerminatedTrinity Sterile, Inc.
Medical DeviceAug 24, 2022
Trinity Sterile Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref recall — FDA Z-1551-2022
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
Class IIFDA: TerminatedTrinity Sterile, Inc.
Medical DeviceAug 24, 2022
Trinity Sterile Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF recall — FDA Z-1550-2022
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
Class IIFDA: TerminatedTrinity Sterile, Inc.
Medical DeviceAug 24, 2022
Trinity Sterile Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF recall — FDA Z-1549-2022
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
Class IIFDA: TerminatedTrinity Sterile, Inc.
Medical DeviceApr 28, 2021
Trinity Sterile Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended recall — FDA Z-1468-2021
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Class IIFDA: TerminatedTrinity Sterile, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Trinity Sterile, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.