Trinity Sterile, Inc.
Dres Change W/Betadyne & Alcohol
1manufacturer
31catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Registered in Hubei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
Record
| Listed by | Trinity Sterile, Inc., United States |
|---|---|
| FDA product code | OXQ |
| Device type | Dressing Change Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-10 |
| Record revised | 2025-11-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 30, pack of 50, pack of 20, pack of 25, pack of 70 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81393 | In distribution | |
| 91393DC | In distribution | |
| 81655 | In distribution | |
| 85381 | In distribution | |
| 7019 | In distribution | |
| 85384 | In distribution | |
| 5055 | In distribution | |
| 81433 | In distribution | |
| 85383 | In distribution | |
| 5056 | In distribution | |
| 81374 | In distribution | |
| 70141 | In distribution | |
| 85376 | In distribution | |
| 5075 | In distribution | |
| 85374 | In distribution | |
| 85261 | In distribution | |
| 85375 | In distribution | |
| 81435 | In distribution | |
| 5074 | In distribution | |
| 81663 | In distribution | |
| 81393B | In distribution | |
| 85377 | In distribution | |
| 81432 | In distribution | |
| 86122 | In distribution | |
| 81436 | In distribution | |
| 81454 | In distribution | |
| 85380 | In distribution | |
| 81427 | In distribution | |
| 81451 | In distribution | |
| 85382 | In distribution | |
| 85315 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 3,005 |
| Medline | Medline Industries, Inc. | 1,428 |
| Centurion | Centurion Medical Products Corporation | 1,319 |
| Medline Industries, Inc. | Medline Industries, Inc. | 218 |
| MedStream | Medical Specialties Distributors, Inc. | 202 |
| Vygon | Vygon Corp. | 112 |
| LSL Healthcare | Lsl Industries, Inc. | 75 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 45 |
| ACS | American Contract Systems, Inc. | 35 |
| Medline | Centurion Medical Products Corporation | 34 |
| DeRoyal | Deroyal Industries, Inc. | 15 |
| Medical Action Industries | Medical Action Industries, Inc. | 15 |
Showing 12 of 30. All products under Dressing Change Tray
Recalls
10 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-12-13 | Class II | Process control | Potential for hole in package compromising sterility of the medical kit. | 1,980 units | |
| 2024-12-13 | Class II | Process control | Potential for hole in package compromising sterility of the medical kit. | 280 units | |
| 2024-12-13 | Class II | Process control | Potential for hole in package compromising sterility of the medical kit. | 5,940 units | |
| 2024-12-13 | Class II | Process control | Potential for hole in package compromising sterility of the medical kit. | 1,980 units | |
| 2024-12-13 | Class II | Process control | Potential for hole in package compromising sterility of the medical kit. | 3,960 units | |
| 2022-06-29 | Class II | Labeling design | 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 | 5 cases (125 eaches ) | 2024-05-10 |
| 2022-06-29 | Class II | Labeling design | 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 | 2,512 cases (75,360 eaches ) | 2024-05-10 |
| 2022-06-29 | Class II | Labeling design | 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 | 4,169 cases (125,070 eaches) | 2024-05-10 |
| 2022-06-29 | Class II | Labeling design | 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 | 1,513 cases (45,390 eaches) | 2024-05-10 |
| 2021-02-23 | Class II | Under Investigation by firm | Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility | 2970 units | 2023-02-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.