Trinity Sterile, Inc.
201 Kiley Dr, SALISBURY, MD, US
Registered product codes
79 product codes
Recent MDR events
8 on file
- KIT CAP CHANGE STERILEApr 14, 2025MalfunctionMW5168981
- VAGINAL SPECULUMApr 5, 2024OtherMW5153592
- VAGINAL SPECULUMApr 5, 2024OtherMW5153593
- DISPOSABLE VAGINAL SPECULUMDec 1, 2023MalfunctionMW5148702
- CENTRAL LINE DRESSING KIT (SPECIFICALLY THE NON-ADHERENT PAD)Jul 7, 2022InjuryMW5110761
- IV START KITJan 8, 2009Malfunction1286203
- TRINITY IV START KIT WITH CHLORAPREP FREPP APPLICATORSep 24, 2007InjuryMW5003893
- TRINITY STERILE INCMar 8, 2007Malfunction2364855
Recalls
10 on file
- Open, ClassifiedJan 22, 2025
Potential for hole in package compromising sterility of the medical kit.
View FDA record ↗ - Open, ClassifiedJan 22, 2025
Potential for hole in package compromising sterility of the medical kit.
View FDA record ↗ - Open, ClassifiedJan 22, 2025
Potential for hole in package compromising sterility of the medical kit.
View FDA record ↗ - Open, ClassifiedJan 22, 2025
Potential for hole in package compromising sterility of the medical kit.
View FDA record ↗ - Open, ClassifiedJan 22, 2025
Potential for hole in package compromising sterility of the medical kit.
View FDA record ↗ - TerminatedUnknown
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗
Compliance history
Matched by FEI 1000123297.
FDA inspections
1 on file
- No Action Indicated (NAI)May 23, 2024
Compliance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.