ACS
LAP Chole - LAP Hernia Pack - 282807
4manufacturers in China registered for this device type
988catalogue numbers in this listing
14recalls on this code
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | FDE |
| Device type | Laparoscopy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2019-11-13 |
| 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 |
|---|---|---|
| PCLC62B | In distribution | |
| PKLC42A | In distribution | |
| UILC71Y | In distribution | |
| AKGR27A | In distribution | |
| MHLP45AK | In distribution | |
| SARB30O | In distribution | |
| FHGL06S | In distribution | |
| SGLC15A | In distribution | |
| LLLS58C | In distribution | |
| SJUL18I | In distribution | |
| SHGE52G | In distribution | |
| AMLA54A | In distribution | |
| SNRP85E | In distribution | |
| UDLC17AA | In distribution | |
| TNLP15M | In distribution | |
| UILC72AC | In distribution | |
| OWLC07I | In distribution | |
| BHRP44K | In distribution | |
| BELR04J | In distribution | |
| BDGL65C | In distribution | |
| LMLH25T | In distribution | |
| SARB30P | In distribution | |
| UDDV99AB | In distribution | |
| ACLC15A | In distribution | |
| WNLC11K | In distribution | |
| AGLC19K | In distribution | |
| MKLA06I | In distribution | |
| ISLB01H | In distribution | |
| RBLA10L | In distribution | |
| ANLP25AC | In distribution | |
| UIRU84Y | In distribution | |
| NRLS81H | In distribution | |
| WVGL60J | In distribution | |
| TPDV16G | In distribution | |
| UIRU84S | In distribution | |
| CXRO12T | In distribution | |
| LKLP32H | In distribution | |
| ESLT53A | In distribution | |
| ACLC15B | In distribution | |
| BPDP87L | In distribution | |
| HSRU15N | In distribution | |
| FRLA69N | In distribution | |
| FHLA23V | In distribution | |
| DVLC11B | In distribution | |
| JOGL43E | In distribution | |
| JFLC10E | In distribution | |
| WNLP08K | In distribution | |
| BRLR14T | In distribution | |
| CMLP45AF | In distribution | |
| FALC02AH | In distribution | |
| RGLC12I | In distribution | |
| PRLC05Z | In distribution | |
| LLLA21K | In distribution | |
| UICH53L | In distribution | |
| UIUA68AE | In distribution | |
| BPLG21K | In distribution | |
| AGKD50N | In distribution | |
| CMLP45AD | In distribution | |
| MHLP45AA | In distribution | |
| JOGL43H | In distribution | |
| IHLA27Y | In distribution | |
| BLLC42M | In distribution | |
| UIUA68T | In distribution | |
| AHLP22K | In distribution | |
| WERK26E | In distribution | |
| IHGB89AB | In distribution | |
| MKLA06J | In distribution | |
| WLLC08A | In distribution | |
| IHDA88AC | In distribution | |
| AGRO47M | In distribution | |
| SMLC53B | In distribution | |
| SSGL30C | In distribution | |
| MMLP40D | In distribution | |
| WNLC11M | In distribution | |
| FILC06K | In distribution | |
| BHRP44M | In distribution | |
| SFLP52U | In distribution | |
| PKLC42C | In distribution | |
| PCLP59B | In distribution | |
| UILC71W | In distribution | |
| EFPG65B | In distribution | |
| TSLC90A | In distribution | |
| UICH53AA | In distribution | |
| HCLC02J | In distribution | |
| UIRG83U | In distribution | |
| JFDO20A | In distribution | |
| MPGL15G | In distribution | |
| WEEN39B | In distribution | |
| SARB30K | In distribution | |
| UDLC17AD | In distribution | |
| AKRB26D | In distribution | |
| FRLC65V | In distribution | |
| FHLA23W | In distribution | |
| LMLH25W | In distribution | |
| SHGY21H | In distribution | |
| SHGY21I | In distribution | |
| PCLP59D | In distribution | |
| FTLC10I | In distribution | |
| BPRB41A | In distribution | |
| LMLA12O | In distribution | |
| HSLP39P | In distribution | |
| SAGL57G | In distribution | |
| GUGE09K | In distribution | |
| LLGB52F | In distribution | |
| AHLP22M | In distribution | |
| AHLP22L | In distribution | |
| CEBR00Q | In distribution | |
| UIUA68X | In distribution | |
| MHLP45Y | In distribution | |
| JELC98H | In distribution | |
| MMGI67H | In distribution | |
| OSDV38D | In distribution | |
| WERP43G | In distribution | |
| MPGL15D | In distribution | |
| UHLC65AE | In distribution | |
| AHLA23Q | In distribution | |
| RGLC12P | In distribution | |
| AGKD50M | In distribution | |
| HOLC64F | In distribution | |
| CXGU11AE | In distribution | |
| WHLC43A | In distribution | |
| BFLC02AA | In distribution | |
| MHLP45AJ | In distribution | |
| LLLA21J | In distribution | |
| OWLC07N | In distribution | |
| UHLC65AF | In distribution | |
| JCLC12C | In distribution | |
| MCLP26B | In distribution | |
| TPDV16D | In distribution | |
| UILC72T | In distribution | |
| SVLC45L | In distribution | |
| AKGR27B | In distribution | |
| LKLC08R | In distribution | |
| IHDA88AH | In distribution | |
| MMLP40A | In distribution | |
| ANPR34S | In distribution | |
| MMLP40H | In distribution | |
| SNGL91I | In distribution | |
| LMLC32T | In distribution | |
| DVLC11C | In distribution | |
| UIRG83AA | In distribution | |
| MMML26G | In distribution | |
| SLDA35H | In distribution | |
| PKLC42E | In distribution | |
| LLLS28G | In distribution | |
| HNLC80I | In distribution | |
| JKLC55F | In distribution | |
| EFML49A | In distribution | |
| SMLC53A | In distribution | |
| ANLP25AH | In distribution | |
| NULC02B | In distribution | |
| IHDA88AE | In distribution | |
| BFLC02AF | In distribution | |
| UDLP19AB | In distribution | |
| COLC12J | In distribution | |
| EVRB95B | In distribution | |
| ISLA06F | In distribution | |
| DVLC11G | In distribution | |
| UDRB88U | In distribution | |
| BFLC02AC | In distribution | |
| DVLC11H | In distribution | |
| EVRO90C | In distribution | |
| HOLC21E | In distribution | |
| ISLB01J | In distribution | |
| IHLC11AB | In distribution | |
| SAGL57I | In distribution | |
| UIUA68V | In distribution | |
| SFLA02A | In distribution | |
| MOLA14K | In distribution | |
| HODV44C | In distribution | |
| LKLC08T | In distribution | |
| PLDA60J | In distribution | |
| HOLC21D | In distribution | |
| YOGL29J | In distribution | |
| PCLP59H | In distribution | |
| UILC71U | In distribution | |
| MHLC19AK | In distribution | |
| ANLP25AD | In distribution | |
| UILC71Z | In distribution | |
| ESLS51B | In distribution | |
| FILC06J | In distribution | |
| MMDA26H | In distribution | |
| AGRO47K | In distribution | |
| PLDA00L | In distribution | |
| OWLC07M | In distribution | |
| MMGL23B | In distribution | |
| CILC69J | In distribution | |
| LMLP08AA | In distribution | |
| JOGL43C | In distribution | |
| MHLP45AG | In distribution | |
| FALC02AF | In distribution | |
| MHLP45AD | In distribution | |
| EVRO90A | In distribution | |
| AMDA42Q | In distribution | |
| UIRU84U | In distribution | |
| UDLP19AC | In distribution | |
| CXLP87AJ | In distribution | |
| MPGL15F | In distribution | |
| EVRB95E | In distribution | |
| MMGL23E | In distribution | |
| UIRG83Z | In distribution | |
| CMLC33AM | In distribution | |
| SLLA21E | In distribution | |
| RBLA10N | In distribution | |
| UDLP19AA | In distribution | |
| FRLA69P | In distribution | |
| UILC71AA | In distribution | |
| OSDV38G | In distribution | |
| AVLC19G | In distribution | |
| WERK26D | In distribution | |
| LMDV37Z | In distribution | |
| RWLA55I | In distribution | |
| FRVL61Q | In distribution | |
| AHLC20P | In distribution | |
| CELC47I | In distribution | |
| UILC72S | In distribution | |
| UDLP19AE | In distribution | |
| UILC71T | In distribution | |
| SFLP52W | In distribution | |
| WNLP08M | In distribution | |
| BELC08I | In distribution | |
| LLGB52I | In distribution | |
| LLGB52M | In distribution | |
| PCLP59C | In distribution | |
| JOPG41E | In distribution | |
| UIRU84AC | In distribution | |
| SWRP15F | In distribution | |
| HNLC80H | In distribution | |
| ISLP03I | In distribution | |
| UDRB88V | In distribution | |
| OWLC07H | In distribution | |
| JELC98I | In distribution | |
| LSRERERVASCA | In distribution | |
| LLGB52J | In distribution | |
| UICH53Y | In distribution | |
| CXLP87AL | In distribution | |
| UILC72X | In distribution | |
| CXRO12X | In distribution | |
| CMLC33AJ | In distribution | |
| AGLC19J | In distribution | |
| PLDA70L | In distribution | |
| NULC02C | In distribution | |
| PCLC62H | In distribution | |
| HGGE28E | In distribution | |
| HOLC64C | In distribution | |
| CWGL81D | In distribution | |
| LLLS58B | In distribution | |
| LLLA21I | In distribution | |
| MHRB88AI | In distribution | |
| SNRP85D | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 23,145 |
| Cardinal Health | Cardinal Health 200, LLC | 9,245 |
| Aligned Medical Solutions | Aligned Medical Solutions | 156 |
| DeRoyal | Deroyal Industries, Inc. | 141 |
| Regard™ | ROi CPS LLC | 122 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 61 |
| Medline | Medline Industries, Inc. | 19 |
| Halyard | Avid Medical, Inc. | 13 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
Showing 12 of 17. All products under Laparoscopy Kit
Recalls Naming This Product
10 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 | 1233 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. | 303 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. | 630 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. | 237 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-01-31 | Class II | Process change control | Sterility assurance with procedure trays | 500 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. | 68 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-06 | Class II | Under Investigation by firm | Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility | 120 |
| 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 | 3196 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 | 56 cases |
| American Contract Systems, Inc. | UDI-DI | 2022-03-22 | Class II | Process control | Product was sterilized with a higher than specification EO concentration. | 20 packs |
Recalls
5 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 | |
| 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 | 1031 units | |
| 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 | |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 39 units | |
| 2020-04-13 | Class II | Process control | The surgical gowns were manufactured in a facility that is not registered by the FDA. | 2, 868 total kits | 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.