Trinity Sterile, Inc.
Salisbury, MD, US
TRINITY STERILE, INC. appears in FDA device records in Salisbury, MD. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1123010 | 1000123297 | TRINITY STERILE, INC. | 201 Kiley Dr, SALISBURY, MD 21801 US | 2026 | and 69 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- FQMBandage, Elastic
- KMEBedding, Disposable, Medical
- GESBlade, Scalpel
- JYCCannula, Ear
- JOLCatheter And Tip, Suction
- BSYCatheters, Suction, Tracheobronchial
- HFXClamp, Circumcision
- FHAClamp, Penile
- GDJClamp, Surgical, General & Plastic Surgery
- FLLContinuous Measurement Thermometer
- JYGCurette, Ear
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- KKXDrape, Surgical, Antimicrobial
- EMJElevator, Surgical, Dental
- EKBExplorer, Operative
- FRLFiber, Medical, Absorbent
- EMIFile, Bone, Surgical
- HTDForceps
- KAEForceps, Ent
- GENForceps, General & Plastic Surgery
- HDAForceps, Obstetrical
- GWXFork, Tuning
- IGCFormalin-Saline
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- HXKHolder, Needle; Orthopedic
- JYLHook, Microsurgical Ear
- DWSInstruments, Surgical, Cardiovascular
- KDDKit, Surgical Instrument, Disposable
- GCJLaparoscope, General & Plastic Surgery
- FHNLigator, Hemorrhoidal
- EAXMirror, Mouth
- DYNMouthpiece, Saliva Ejector
- HHWPessary, Vaginal
- JEXPlier, Orthodontic
- HNLProbe, Lachrymal
- EMEPunch, Biopsy, Surgical
- GADRetractor
- FNSRing Cutter
- HTXRongeur
- GDRSaw, Manual And Accessories
- GDXScalpel, One-Piece
- KBWScrew, Oral
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- FBXSound, Urethral, Metal Or Plastic
- HHMSound, Uterine
- HNDSpatula, Ophthalmic
- GAFSpatula, Surgical, General & Plastic Surgery
- FFQSpeculum, Rectal
- HDFSpeculum, Vaginal, Metal
- HIBSpeculum, Vaginal, Nonmetal
- ILHSplint, Hand, And Components
- GDTStaple, Removable (Skin)
- KGXTape And Bandage, Adhesive
- GAXTourniquet, Nonpneumatic
- FCHTray, Biopsy, Without Biopsy Instruments
- FSMTray, Surgical, Instrument
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | Potential for hole in package compromising sterility of the medical kit. | Class II | Open, Classified | |
| 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 | Potential for hole in package compromising sterility of the medical kit. | Class II | Open, Classified | |
| 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 | Potential for hole in package compromising sterility of the medical kit. | Class II | Open, Classified | |
| 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 | Potential for hole in package compromising sterility of the medical kit. | Class II | Open, Classified | |
| 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 | Potential for hole in package compromising sterility of the medical kit. | Class II | Open, Classified | |
| Z-1551-2022 | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF | 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 II | Terminated | |
| Z-1550-2022 | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF | 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 II | Terminated | |
| Z-1549-2022 | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF | 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 II | Terminated | |
| Z-1548-2022 | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | 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 II | Terminated | |
| 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 | Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain