ACS
Interventional Radiology Pack - 170216
1manufacturer
344catalogue numbers in this listing
8recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | OES |
| Device type | Cardiac Catheterization Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2024-03-20 |
| Record revised | 2022-06-17 (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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EVLH67E | In distribution | |
| MMCE16I | In distribution | |
| FTCL83J | In distribution | |
| AGRH34H | In distribution | |
| SLCT10H | In distribution | |
| SLBT02G | In distribution | |
| BHCA49J | In distribution | |
| LKCC01Z | In distribution | |
| SHCC17H | In distribution | |
| HZCC52C | In distribution | |
| BLCL72K | In distribution | |
| UDIR58AM | In distribution | |
| LLCA38I | In distribution | |
| GSCC40E | In distribution | |
| HGMA13F | In distribution | |
| TMCC25I | In distribution | |
| WBCC10E | In distribution | |
| OGCL30B | In distribution | |
| OGAN60D | In distribution | |
| NBCA40G | In distribution | |
| SHIR38G | In distribution | |
| TMCC25H | In distribution | |
| UDIN23AK | In distribution | |
| SHPA15I | In distribution | |
| EMCC38E | In distribution | |
| BBCP09C | In distribution | |
| IHCC03Q | In distribution | |
| SACL75AP | In distribution | |
| FDCI70H | In distribution | |
| SVHC26F | In distribution | |
| HGTV60F | In distribution | |
| BPRD66A | In distribution | |
| WHCL01E | In distribution | |
| FTCL83K | In distribution | |
| AGLH66G | In distribution | |
| SBAN97C | In distribution | |
| FTCL83I | In distribution | |
| TNCC02AC | In distribution | |
| AHCC27Y | In distribution | |
| UMCA90D | In distribution | |
| SHCA31I | In distribution | |
| AMCL05O | In distribution | |
| MMCC14H | In distribution | |
| FHCC26O | In distribution | |
| COCC01A | In distribution | |
| FBHC45I | In distribution | |
| BMIN42E | In distribution | |
| WPHC45F | In distribution | |
| DFCA01K | In distribution | |
| UDIR58AK | In distribution | |
| AGRH34F | In distribution | |
| LLTV10A | In distribution | |
| SACL75AN | In distribution | |
| UICC27Z | In distribution | |
| LBPC24B | In distribution | |
| HGTV60E | In distribution | |
| OGCL30A | In distribution | |
| BPRC87A | In distribution | |
| AGRH34K | In distribution | |
| CXDP36P | In distribution | |
| LLTV10B | In distribution | |
| HIBL84L | In distribution | |
| AGRH34G | In distribution | |
| CECL02O | In distribution | |
| HIMO37F | In distribution | |
| MHIR99AJ | In distribution | |
| DMPC72K | In distribution | |
| HHCC56E | In distribution | |
| AMCL05M | In distribution | |
| GBCC47E | In distribution | |
| COCC01D | In distribution | |
| SLBT02K | In distribution | |
| UICC27AE | In distribution | |
| IHCC03R | In distribution | |
| SVHC26H | In distribution | |
| SHCC17G | In distribution | |
| MPCA63J | In distribution | |
| SLBT02I | In distribution | |
| AGRH34L | In distribution | |
| IHCC03W | In distribution | |
| TNCC02AD | In distribution | |
| FDCL22S | In distribution | |
| BLCL72L | In distribution | |
| AGLH66H | In distribution | |
| COCC01B | In distribution | |
| LSRCARDCATHH | In distribution | |
| SHPA15G | In distribution | |
| EVLH67F | In distribution | |
| UDIN23AL | In distribution | |
| HHCC56D | In distribution | |
| MHMT60A | In distribution | |
| SLBT02H | In distribution | |
| SHPA15F | In distribution | |
| MECL20V | In distribution | |
| NBCA40D | In distribution | |
| HIBL84G | In distribution | |
| HIBL84K | In distribution | |
| HGCL69J | In distribution | |
| CGCL44I | In distribution | |
| CGCL44J | In distribution | |
| UDIN23AF | In distribution | |
| UDIN23AD | In distribution | |
| UDCP24AA | In distribution | |
| FHCC26M | In distribution | |
| JRHC45K | In distribution | |
| LBAN62B | In distribution | |
| AGRH34I | In distribution | |
| LKCC01V | In distribution | |
| SLBT02L | In distribution | |
| WPHC45E | In distribution | |
| WHCL51E | In distribution | |
| EMCT17I | In distribution | |
| WHCL51G | In distribution | |
| GSCC40F | In distribution | |
| UDIR58AL | In distribution | |
| IHCC03T | In distribution | |
| MHCL28J | In distribution | |
| COCC01C | In distribution | |
| MHIR99AH | In distribution | |
| UICC27AA | In distribution | |
| WBEP02D | In distribution | |
| JRHC45H | In distribution | |
| UIRD89AH | In distribution | |
| EVLH67D | In distribution | |
| HHTB21G | In distribution | |
| HIBL84H | In distribution | |
| TNCC02X | In distribution | |
| MECL20S | In distribution | |
| UMCA90E | In distribution | |
| CEEV16J | In distribution | |
| RWCL64I | In distribution | |
| FDCL22T | In distribution | |
| TNCC02AE | In distribution | |
| SHDW24H | In distribution | |
| CXPA35P | In distribution | |
| IHCC03O | In distribution | |
| JRHC45G | In distribution | |
| SVHC26G | In distribution | |
| LLCL47E | In distribution | |
| CECL02K | In distribution | |
| UDIN23AE | In distribution | |
| OGAN60B | In distribution | |
| LKCC01W | In distribution | |
| KPHC81L | In distribution | |
| HHTV79E | In distribution | |
| CEEV16I | In distribution | |
| MECL20T | In distribution | |
| TOVP55A | In distribution | |
| OGAN60A | In distribution | |
| FICA08N | In distribution | |
| FBHC45G | In distribution | |
| ANIR77AL | In distribution | |
| IHCC03X | In distribution | |
| HHCC56C | In distribution | |
| UHIR20AF | In distribution | |
| FDCL22O | In distribution | |
| BHTV87C | In distribution | |
| CXDP36O | In distribution | |
| LBAN62C | In distribution | |
| COCC01E | In distribution | |
| GBCC47B | In distribution | |
| HHCC56G | In distribution | |
| HHTV79F | In distribution | |
| AHCC27W | In distribution | |
| OGCL30D | In distribution | |
| HHTV79D | In distribution | |
| SJCA21G | In distribution | |
| JEPC04L | In distribution | |
| HGCL69F | In distribution | |
| EMCC38G | In distribution | |
| HHCC56I | In distribution | |
| HGCL69I | In distribution | |
| EFRD68C | In distribution | |
| WPPI47H | In distribution | |
| CECL02H | In distribution | |
| BLCL72M | In distribution | |
| RWCL64J | In distribution | |
| LLTV10C | In distribution | |
| HHCC56H | In distribution | |
| FHCC26N | In distribution | |
| AGLH66H | In distribution | |
| AGLH66I | In distribution | |
| WPHC45D | In distribution | |
| WETV12A | In distribution | |
| MECL20U | In distribution | |
| UHIR20AG | In distribution | |
| MECL20W | In distribution | |
| GMCR72G | In distribution | |
| LKCC01Y | In distribution | |
| SLCC11N | In distribution | |
| ILCL01M | In distribution | |
| SVHC26K | In distribution | |
| SBAN97A | In distribution | |
| GBVA18D | In distribution | |
| SACF78F | In distribution | |
| NBCA40F | In distribution | |
| LLCL47G | In distribution | |
| ANCT20V | In distribution | |
| UICC27V | In distribution | |
| LKCC01U | In distribution | |
| SACL75AM | In distribution | |
| MHIR99AK | In distribution | |
| AKIN85A | In distribution | |
| CXPA35N | In distribution | |
| AHCC27Z | In distribution | |
| GMCR72H | In distribution | |
| SACL75AL | In distribution | |
| EFRD68D | In distribution | |
| SHCA31J | In distribution | |
| TMCC25J | In distribution | |
| AGLH66F | In distribution | |
| CECL02I | In distribution | |
| UICC27AB | In distribution | |
| LLCL47H | In distribution | |
| HGMA13G | In distribution | |
| UICC27X | In distribution | |
| FBHC45J | In distribution | |
| SHCC00E | In distribution | |
| LBAN62A | In distribution | |
| GSCC40G | In distribution | |
| AHCC27X | In distribution | |
| SACL75AO | In distribution | |
| FDCL22N | In distribution | |
| AHCC27T | In distribution | |
| MHIR99AI | In distribution | |
| SJCH22G | In distribution | |
| ANIR77AG | In distribution | |
| MECL20X | In distribution | |
| CECL02M | In distribution | |
| LLCA38F | In distribution | |
| UDIN23AI | In distribution | |
| CEEP05G | In distribution | |
| FICA08M | In distribution | |
| HIBL84J | In distribution | |
| SHCC00F | In distribution | |
| DMCC24J | In distribution | |
| FBHC45H | In distribution | |
| SACL75AK | In distribution | |
| FDCL22L | In distribution | |
| TNCC02Y | In distribution | |
| SBPM82A | In distribution | |
| FHCC26J | In distribution | |
| ANIR77AI | In distribution | |
| SHIR38F | In distribution | |
| LBPC24A | In distribution | |
| BWCP17B | In distribution | |
| AHCC27U | In distribution | |
| HGCL69G | In distribution | |
| LSRCATHEPLABA | In distribution | |
| FICA08K | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 7,486 |
| Cardinal Health | Cardinal Health 200, LLC | 2,706 |
| Avid TruCustom | Avid Medical, Inc. | 1,173 |
| Centurion | Centurion Medical Products Corporation | 1,077 |
| Halyard | Avid Medical, Inc. | 1,032 |
| Medline Industries, Inc. | Centurion Medical Products Corporation | 775 |
| Medline | Medline Industries, Inc. | 465 |
| Regard™ | ROi CPS LLC | 138 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 79 |
| Aligned Medical Solutions | Aligned Medical Solutions | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 24 |
| Namic | Medline Industries, Inc. | 14 |
Showing 12 of 18. All products under Cardiac Catheterization Kit
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| American Contract Systems, Inc. | UDI-DI | 2025-01-31 | Class II | Process change control | Sterility assurance with procedure trays | 460 kits. |
| American Contract Systems, Inc. | UDI-DI | 2024-08-07 | Class II | Under Investigation by firm | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. | 1 unit |
| American Contract Systems, Inc. | UDI-DI | 2023-11-29 | Class II | Process control | During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the “piggybacked” components were assessed | 4394 units |
| American Contract Systems, Inc. | UDI-DI | 2023-09-01 | Class II | Process control | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher | 96 cases |
| American Contract Systems, Inc. | UDI-DI | 2023-09-01 | Class II | Process control | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher | 1260 units |
| American Contract Systems, Inc. | UDI-DI | 2022-03-22 | Class II | Process control | Product was sterilized with a higher than specification EO concentration. | 10 packs |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2025-09-04 | Class II | Nonconforming Material/Component | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycle | 32,433 total | |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 61 units | |
| 2020-04-13 | Class II | Process control | The surgical gowns were manufactured in a facility that is not registered by the FDA. | 2868 kits total | 2020-11-25 |
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.