ICU Medical, Inc.
GTIN for CH-19, 1/EA
1manufacturer
1catalogue number
4510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | ONB |
| Device type | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K173477 |
| Record published | 2025-04-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CH-19 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 255 |
| Equashield | Equashield Medical Ltd | 83 |
| BD PhaSeal | BD Switzerland Sàrl | 23 |
| Halo | J & J Solutions, Inc. | 14 |
| ProSeal Cstd | Epic International (Thailand) Co., Ltd. | 12 |
| BD PhaSeal Optima | BD Switzerland Sàrl | 11 |
| Equashield Cstd | Equashield Medical Ltd | 6 |
| Luer Lock Adaptor 2 Swivel A | Equashield Medical Ltd | 1 |
| OnGuard®2 Cstd Luer Lock Adaptor | Simplivia Healthcare Ltd. | 1 |
| OnGuard2 Syringe Adaptor, 5 Units | Simplivia Healthcare Ltd. | 1 |
| OnGuard 2 Cstd Bag Adaptor LL with Ultrasite | Simplivia Healthcare Ltd. | 1 |
| Tevadaptor Catheter Adaptor | Simplivia Healthcare Ltd. | 1 |
Showing 12 of 60. All products under Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190157 | 2019-10-23 |
| K173477 | 2018-08-31 |
| K170110 | 2018-08-10 |
| K131549 | 2013-07-26 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, | 28,550 |
| ICU Medical, Inc | 510(k) number | 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and | 6,105,468 |
| ICU Medical, Inc | 510(k) number | 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | |
| ICU Medical, Inc | 510(k) number | 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | |
| ICU Medical, Inc | 510(k) number | 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | |
| ICU Medical, Inc | 510(k) number | 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | |
| ICU Medical, Inc | 510(k) number | 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | |
| ICU Medical, Inc | 510(k) number | 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 534764 |
Recalls
38 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 |
|---|---|---|---|---|
| 2026-03-24 | Class II | Process control | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential f | 20,506 |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 11000 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2450 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 6450 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 150 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 8475 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 11000 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 16850 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 133,255 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 6150 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 600 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 900 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 3350 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 80 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 400 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 1100 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 11200 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 3000 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2000 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 1600 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 5700 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2000 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 875 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 134,700 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 4000 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2100 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 202900 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 53,050 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 950 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 1700 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 7950 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 950 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 9004 units |
| 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 134700 units |
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.