ACS
Open Heart NON-Ster Bundle-Drwstring BAG
1manufacturer
1,540catalogue numbers in this listing
21recalls 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 | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2020-07-15 |
| Record revised | 2022-06-17 (version 5) |
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 |
|---|---|---|
| MHCV04F | In distribution | |
| JROH00L | In distribution | |
| MHCV45Q | In distribution | |
| LLPD90E | In distribution | |
| UDFP36AE | In distribution | |
| BHVA33G | In distribution | |
| LLOH52G | In distribution | |
| BHCA27G | In distribution | |
| IHVE17AN | In distribution | |
| MHCV21G | In distribution | |
| ANVA82P | In distribution | |
| BHVA33D | In distribution | |
| LBCV51A | In distribution | |
| HIVA31F | In distribution | |
| SVMN60H | In distribution | |
| CXCV01AV | In distribution | |
| MCVA55E | In distribution | |
| FHPA27L | In distribution | |
| HOTO66E | In distribution | |
| AGPV28P | In distribution | |
| AGOH98T | In distribution | |
| UDIP97AJ | In distribution | |
| ANEP76AI | In distribution | |
| AMMV04AE | In distribution | |
| MHCV55K | In distribution | |
| CXCV01AW | In distribution | |
| BLCV78O | In distribution | |
| MMPM27G | In distribution | |
| FIOH02S | In distribution | |
| JROH00M | In distribution | |
| MHCV43K | In distribution | |
| LLOH01J | In distribution | |
| MHCV74I | In distribution | |
| SLEP03I | In distribution | |
| AMOH32AK | In distribution | |
| UTAV77T | In distribution | |
| SVOH38S | In distribution | |
| UDBH37AW | In distribution | |
| UTTC82Z | In distribution | |
| RCOH61E | In distribution | |
| FHPA27J | In distribution | |
| UDAV16AC | In distribution | |
| ANVA82W | In distribution | |
| IHAV18AQ | In distribution | |
| CECV12Z | In distribution | |
| JROH97L | In distribution | |
| FRVA25K | In distribution | |
| HHIR34G | In distribution | |
| MTVS73D | In distribution | |
| UMVA20D | In distribution | |
| HHOH16G | In distribution | |
| SHPM15E | In distribution | |
| TODM01S | In distribution | |
| NCOH00I | In distribution | |
| UIPM82U | In distribution | |
| LLOP25G | In distribution | |
| MHCV64I | In distribution | |
| UICS88R | In distribution | |
| UDAV16AB | In distribution | |
| LLPA19I | In distribution | |
| AGOH97M | In distribution | |
| MMAV18I | In distribution | |
| BLPA73P | In distribution | |
| LLPA19G | In distribution | |
| IHAV18AL | In distribution | |
| MMTR12C | In distribution | |
| CECV12Q | In distribution | |
| MHCV64F | In distribution | |
| UDCP24AC | In distribution | |
| CECV12T | In distribution | |
| EMPM16H | In distribution | |
| MPCM80I | In distribution | |
| WEVA30B | In distribution | |
| BHOH43H | In distribution | |
| IHOH21BN | In distribution | |
| SHVA17J | In distribution | |
| RCAV40C | In distribution | |
| LMAG20F | In distribution | |
| SJOH23C | In distribution | |
| CEIM06H | In distribution | |
| LLPA19K | In distribution | |
| MECV98W | In distribution | |
| HSPA80S | In distribution | |
| WECV24E | In distribution | |
| TNCD09I | In distribution | |
| OLPM80B | In distribution | |
| BHOH94L | In distribution | |
| LSRCFHENDAE | In distribution | |
| IHPK06X | In distribution | |
| BHOP48K | In distribution | |
| AMEV36C | In distribution | |
| BHTY48N | In distribution | |
| SBHT94B | In distribution | |
| TPIR15B | In distribution | |
| LLOH52K | In distribution | |
| BHOH43J | In distribution | |
| ANCV78AN | In distribution | |
| ANIR77AD | In distribution | |
| UIVW15L | In distribution | |
| ESCC82B | In distribution | |
| MHCV74H | In distribution | |
| BHVP49J | In distribution | |
| ANCV78AV | In distribution | |
| TOPH14O | In distribution | |
| BHOH43L | In distribution | |
| DMPM42H | In distribution | |
| FDGV02Z | In distribution | |
| IHPK06U | In distribution | |
| MELL44J | In distribution | |
| LAPM00H | In distribution | |
| MCCB86C | In distribution | |
| NCPM16G | In distribution | |
| CXCV03AV | In distribution | |
| MMCV98U | In distribution | |
| LKEP42K | In distribution | |
| FHPM10R | In distribution | |
| YOPM46A | In distribution | |
| ANVA82Y | In distribution | |
| UITC53AH | In distribution | |
| EFMC25A | In distribution | |
| UHPP82AE | In distribution | |
| TOCV58T | In distribution | |
| MHCV76H | In distribution | |
| HHPK64B | In distribution | |
| LAPM00J | In distribution | |
| MTVS73B | In distribution | |
| NCEN71H | In distribution | |
| MHCV14N | In distribution | |
| WHCA19D | In distribution | |
| AMOH01AH | In distribution | |
| LMCV54O | In distribution | |
| MMPT70G | In distribution | |
| MHCV93H | In distribution | |
| RGAV01C | In distribution | |
| TNAA07P | In distribution | |
| MMOH64C | In distribution | |
| LLOH01D | In distribution | |
| TNCB10AH | In distribution | |
| AGDI40L | In distribution | |
| LMOH50AG | In distribution | |
| SAVA91K | In distribution | |
| FIVA03N | In distribution | |
| EFOH35A | In distribution | |
| FBOH98K | In distribution | |
| FDGV02AD | In distribution | |
| ESEV54A | In distribution | |
| IHOH21BO | In distribution | |
| EFOH00A | In distribution | |
| DVHT60G | In distribution | |
| UIPD03M | In distribution | |
| LMOH50AC | In distribution | |
| UDBH37AS | In distribution | |
| TOCT59B | In distribution | |
| HHOH16E | In distribution | |
| MECV99AB | In distribution | |
| FRCA60AI | In distribution | |
| LSRSMTAVRF | In distribution | |
| MHCV64J | In distribution | |
| JCEP52E | In distribution | |
| SASA24F | In distribution | |
| AGBI64J | In distribution | |
| WLPU00A | In distribution | |
| EMPM16G | In distribution | |
| FHHR16W | In distribution | |
| AMMV04AA | In distribution | |
| SHEP12F | In distribution | |
| GBPR61F | In distribution | |
| MMCV98R | In distribution | |
| MHCV76B | In distribution | |
| ANCV60AH | In distribution | |
| HIVA31H | In distribution | |
| SHHT32I | In distribution | |
| CXCV03AX | In distribution | |
| GIPA83D | In distribution | |
| FTVC35I | In distribution | |
| TNCB10AK | In distribution | |
| CECV12R | In distribution | |
| MHEP38AO | In distribution | |
| MHCV43I | In distribution | |
| UDCP24AF | In distribution | |
| CETH15K | In distribution | |
| FBOH00M | In distribution | |
| EFMC25B | In distribution | |
| UMTH19D | In distribution | |
| LAPM00I | In distribution | |
| FRVA25J | In distribution | |
| GSPM18F | In distribution | |
| MHCV74J | In distribution | |
| UDCP24AD | In distribution | |
| UICS88O | In distribution | |
| MHPP97AO | In distribution | |
| SVOH38O | In distribution | |
| FHHR16T | In distribution | |
| HGOH99H | In distribution | |
| HIVA31I | In distribution | |
| UICT16F | In distribution | |
| MCCB86B | In distribution | |
| BPPM23B | In distribution | |
| LBPM38A | In distribution | |
| LLOH00C | In distribution | |
| LSRDUALPACEB | In distribution | |
| FHTV15A | In distribution | |
| UDBH37AR | In distribution | |
| CEEV16L | In distribution | |
| NMEM38O | In distribution | |
| AMME21H | In distribution | |
| LSRCFHPACRE | In distribution | |
| UICS88P | In distribution | |
| LLOH01E | In distribution | |
| HHPK64G | In distribution | |
| WECV24D | In distribution | |
| MEAN16S | In distribution | |
| CEFS17H | In distribution | |
| MECV96Y | In distribution | |
| UDBH37AO | In distribution | |
| ANVA82AA | In distribution | |
| IHAV18AS | In distribution | |
| MPAA44E | In distribution | |
| ILPP05O | In distribution | |
| CDBB94F | In distribution | |
| ESFT85B | In distribution | |
| MTCD28B | In distribution | |
| UDBH37AV | In distribution | |
| UHPP82AF | In distribution | |
| FDFS87K | In distribution | |
| MHCV10AK | In distribution | |
| MHCV76D | In distribution | |
| FRVA25D | In distribution | |
| MHCV16J | In distribution | |
| MHCV04E | In distribution | |
| BHTV87D | In distribution | |
| NCOH11G | In distribution | |
| FDCR00Z | In distribution | |
| BHMJ60E | In distribution | |
| JSMO14D | In distribution | |
| SLCV01F | In distribution | |
| MHVN88Q | In distribution | |
| MHPP97AQ | In distribution | |
| COPM11B | In distribution | |
| ANCV78BC | In distribution | |
| ANCV55N | In distribution | |
| OSVS48B | In distribution | |
| SVMN60I | In distribution | |
| BHPM60H | In distribution | |
| FTPM87H | In distribution | |
| HIPP64L | In distribution | |
| MTEP61C | In distribution | |
| SLVP23D | In distribution | |
| SHTH38I | In distribution | |
| UTMV78V | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 40,731 |
| Medline Industries, Inc. | Medline Industries, Inc. | 17,468 |
| Avid TruCustom | Avid Medical, Inc. | 2,785 |
| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
| Halyard | Avid Medical, Inc. | 2,108 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Regard™ | ROi CPS LLC | 192 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 51 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls Naming This Product
14 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 | 2025-07-14 | Class II | Under Investigation by firm | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS | 31506 units |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 90 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 90 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 147 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 54 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 40 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 48 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. | 20 units |
| 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. | 93 units |
| 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. | 504 units |
| 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. | 3 units |
| 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 | 12291 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 | 72 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 | 84 cases |
Recalls
7 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 |
|---|---|---|---|---|
| 2026-06-29 | Class II | Nonconforming Material/Component | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications | 30 units |
| 2026-06-29 | Class II | Nonconforming Material/Component | The Convenience Kits contain Medline’s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications | 12 units |
| 2026-06-29 | Class II | Nonconforming Material/Component | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications | 30 units |
| 2026-06-29 | Class II | Nonconforming Material/Component | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications | 30 units |
| 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 |
| 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 134 kits |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 24 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.