ACS
ASC Varicose Vein SET-UP Pack(PS 103337)
24manufacturers in China registered for this device type
10,337catalogue numbers in this listing
20recalls on this code
Who Else Makes It
Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 7 |
| 3A Medical Products Co., Ltd. | Liu An | Anhui | Contract manufacturer | 6 |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan | Anhui | Contract manufacturer | 6 |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 6 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2023-03-29 |
| 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 |
| Distribution end date | 2020-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MPCK01H | In distribution | |
| FLTK06M | In distribution | |
| FDCL22M | In distribution | |
| UIOL34V | In distribution | |
| WVTH28A | In distribution | |
| RWCR92D | In distribution | |
| LSRVPSHUNTB | In distribution | |
| PLTK70B | In distribution | |
| AHCS50W | In distribution | |
| ANCV78AI | In distribution | |
| SAAR74P | In distribution | |
| BFMJ03W | In distribution | |
| HSCS64E | In distribution | |
| UTKT79V | In distribution | |
| AKBS72B | In distribution | |
| WMMJ72E | In distribution | |
| LVTJ65A | In distribution | |
| BHCR22I | In distribution | |
| BOMN62G | In distribution | |
| AKBS72D | In distribution | |
| AGBR90E | In distribution | |
| GSPU24D | In distribution | |
| AMPL36P | In distribution | |
| IHKB89B | In distribution | |
| SCLP01B | In distribution | |
| LLMI66B | In distribution | |
| MDHK62F | In distribution | |
| EDGY05C | In distribution | |
| AGTP44L | In distribution | |
| BHMN18E | In distribution | |
| LLPC47A | In distribution | |
| BHAD99A | In distribution | |
| TXPR11B | In distribution | |
| WHCT10E | In distribution | |
| SMSA40B | In distribution | |
| MMAN10I | In distribution | |
| KPLM43K | In distribution | |
| OLPD06C | In distribution | |
| SPCS60M | In distribution | |
| SLMB18E | In distribution | |
| FHVG13P | In distribution | |
| MYLA11E | In distribution | |
| OWBS11O | In distribution | |
| UIVS92L | In distribution | |
| TNGL26H | In distribution | |
| UIBO67H | In distribution | |
| FLBM16E | In distribution | |
| LWKN46L | In distribution | |
| LVUR50A | In distribution | |
| LLBH34A | In distribution | |
| HOUN28B | In distribution | |
| LLOH31B | In distribution | |
| AGTP45J | In distribution | |
| RBTJ18G | In distribution | |
| HSLM53N | In distribution | |
| JOMP39B | In distribution | |
| SPFT52I | In distribution | |
| UIGS55V | In distribution | |
| TOPA11P | In distribution | |
| WXMI14I | In distribution | |
| ANCH89D | In distribution | |
| UIED00A | In distribution | |
| DMPP16D | In distribution | |
| SGBA07A | In distribution | |
| HECV03AA | In distribution | |
| FLSP41E | In distribution | |
| ILAH89D | In distribution | |
| SJCA21D | In distribution | |
| UIMU65A | In distribution | |
| UIOL35L | In distribution | |
| PRTK23S | In distribution | |
| NBMP80A | In distribution | |
| RWBR57K | In distribution | |
| HGOB99D | In distribution | |
| WHGY91A | In distribution | |
| AHLA17H | In distribution | |
| UIPA61L | In distribution | |
| STCS06I | In distribution | |
| IHAV18AG | In distribution | |
| UHPE29T | In distribution | |
| BESH02I | In distribution | |
| IHPD14AF | In distribution | |
| EGHN05D | In distribution | |
| CRLE02S | In distribution | |
| ICFT45D | In distribution | |
| UDIR58AG | In distribution | |
| VESH51D | In distribution | |
| SPHB56Q | In distribution | |
| FHGS21Y | In distribution | |
| HELP75Z | In distribution | |
| SHEX34D | In distribution | |
| TODR34D | In distribution | |
| OWLC07F | In distribution | |
| WHTK06A | In distribution | |
| UILG41C | In distribution | |
| SVOH38L | In distribution | |
| BHHD26E | In distribution | |
| AJAR10B | In distribution | |
| BHLV40G | In distribution | |
| RBCS12P | In distribution | |
| SHCC17E | In distribution | |
| CCAR18C | In distribution | |
| CDTT00H | In distribution | |
| HCCT05I | In distribution | |
| SLVD11H | In distribution | |
| HECY92N | In distribution | |
| UPES02B | In distribution | |
| MHLT55AA | In distribution | |
| FABM01AB | In distribution | |
| BHOP48F | In distribution | |
| SHKN28C | In distribution | |
| MWMJ45E | In distribution | |
| MRDC13K | In distribution | |
| MWMJ45M | In distribution | |
| MEMV17P | In distribution | |
| AGBA20G | In distribution | |
| LSRNSGWNXLA | In distribution | |
| MHTH90Z | In distribution | |
| CXLP87AG | In distribution | |
| BCSS02H | In distribution | |
| UHSH77AB | In distribution | |
| SWRP15E | In distribution | |
| BLEX03A | In distribution | |
| SHCS30B | In distribution | |
| SMUN05E | In distribution | |
| MHHY11L | In distribution | |
| BLHS11D | In distribution | |
| ANAN51X | In distribution | |
| CILC69C | In distribution | |
| TNSC15C | In distribution | |
| HISU54G | In distribution | |
| BRLR14M | In distribution | |
| LLTL34D | In distribution | |
| HSKA48F | In distribution | |
| IHMJ51AA | In distribution | |
| UIGS77AA | In distribution | |
| LMUP56N | In distribution | |
| FLLG21H | In distribution | |
| SNGY99E | In distribution | |
| MLNK01C | In distribution | |
| LLEO66D | In distribution | |
| AVHA64G | In distribution | |
| LLPL31C | In distribution | |
| UIGS55AF | In distribution | |
| BLSA05A | In distribution | |
| GIPA83B | In distribution | |
| SHEN44D | In distribution | |
| BHCA01J | In distribution | |
| MPMU11E | In distribution | |
| SFLM54W | In distribution | |
| BRLR14N | In distribution | |
| CRHS08R | In distribution | |
| HSHI92I | In distribution | |
| FDCI70E | In distribution | |
| MHLV30K | In distribution | |
| UPVD01D | In distribution | |
| LMTJ06J | In distribution | |
| PRTU21J | In distribution | |
| NMBP44I | In distribution | |
| UICY11F | In distribution | |
| MPKK10A | In distribution | |
| FHPM10M | In distribution | |
| HGOB00E | In distribution | |
| SVER48F | In distribution | |
| LMUB07Q | In distribution | |
| SLTK18D | In distribution | |
| LMAG01K | In distribution | |
| UDLP19X | In distribution | |
| SAGY82R | In distribution | |
| UTTH37U | In distribution | |
| CCMN06C | In distribution | |
| RBCY28E | In distribution | |
| MHSP37E | In distribution | |
| MELS29B | In distribution | |
| AMAH40C | In distribution | |
| NRLI87E | In distribution | |
| PCUB26G | In distribution | |
| LSRBIOPSYA | In distribution | |
| MHEX45W | In distribution | |
| GIGR22G | In distribution | |
| BHPM60E | In distribution | |
| CDCO11E | In distribution | |
| UIAN43D | In distribution | |
| FRCY56D | In distribution | |
| SFBD50X | In distribution | |
| MIBW71A | In distribution | |
| BFTH06Q | In distribution | |
| GNMJ01G | In distribution | |
| OSHN17C | In distribution | |
| CDAV04G | In distribution | |
| UTTK33AE | In distribution | |
| OWGY11F | In distribution | |
| SKMO02K | In distribution | |
| CHAR01I | In distribution | |
| ISAR20C | In distribution | |
| AKGN82A | In distribution | |
| EGAC01A | In distribution | |
| HGAR20A | In distribution | |
| IHTA23R | In distribution | |
| SLGG63D | In distribution | |
| JROH97J | In distribution | |
| SBCS11S | In distribution | |
| BFMA01U | In distribution | |
| WLCS02C | In distribution | |
| CCCS33A | In distribution | |
| TOMN07L | In distribution | |
| UIPD03I | In distribution | |
| HSMI66K | In distribution | |
| AHDR33D | In distribution | |
| AGMI14J | In distribution | |
| ANMP92B | In distribution | |
| LKCS09R | In distribution | |
| UILP16O | In distribution | |
| LMRF28J | In distribution | |
| OSMN28A | In distribution | |
| NMTK31L | In distribution | |
| SPFT52J | In distribution | |
| TOCL51V | In distribution | |
| HGMI12E | In distribution | |
| HOBA16D | In distribution | |
| HSFE66D | In distribution | |
| ANLJ00C | In distribution | |
| BLPD65H | In distribution | |
| LLPP14B | In distribution | |
| SLTK16L | In distribution | |
| PDPP22E | In distribution | |
| UIKN28AA | In distribution | |
| UICP01B | In distribution | |
| LLEC31I | In distribution | |
| SNDC94C | In distribution | |
| UTAR10O | In distribution | |
| UIGY37Q | In distribution | |
| BHCS31E | In distribution | |
| LMTP16AG | In distribution | |
| GIBB05E | In distribution | |
| SHFI42C | In distribution | |
| MPCS72D | In distribution | |
| IHDC30L | In distribution | |
| LLMB38C | In distribution | |
| LSRSMVEINB | In distribution | |
| UIAO72AB | In distribution | |
| CDTY52C | In distribution | |
| BFBA01B | In distribution | |
| WHTK80C | In distribution | |
| LBTK39L | In distribution | |
| MOLA14E | In distribution | |
| HKBP51D | In distribution | |
| BLEA32J | In distribution | |
| HNEX60D | In distribution | |
| AKGN82B | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 67,931 |
| Medline Industries, Inc. | Medline Industries, Inc. | 54,362 |
| Avid TruCustom | Avid Medical, Inc. | 13,498 |
| Halyard | Avid Medical, Inc. | 12,802 |
| SurgiTrack | Owens & Minor Distribution, Inc. | 5,575 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3,490 |
| SurgiTrackSM | Owens & Minor Distribution, Inc. | 3,364 |
| DeRoyal | Deroyal Industries, Inc. | 2,770 |
| Medline | Medline Industries, Inc. | 1,960 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
| Centurion | Centurion Medical Products Corporation | 672 |
Showing 12 of 113. All products under General Surgery Tray
Recalls Naming This Product
19 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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 | 6617 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. | 1200 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. | 17 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. | 41 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. | 690 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. | 690 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. | 534 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. | 280 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 | 90 | |
| 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 | 2023-11-29 | 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 | 290 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 | 1031 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 | 7881 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 | 940 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 | 57 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 | 36 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 | 112 cases | |
| American Contract Systems, Inc. | UDI-DI | 2022-10-12 | Class II | Employee error | Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label. | 1504 trays | 2025-03-06 |
| American Contract Systems, Inc. | UDI-DI | 2022-05-02 | Class I | Process control | Affected products were assembled off-site by individuals who may not have been properly trained. | 274,400 kits total |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2026-03-19 | Class I | Nonconforming Material/Component | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard expos | 7,311 kits | |
| 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 | |
| 2023-09-01 | 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 | |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 116 | |
| 2020-04-13 | Class II | Process control | The surgical gowns were manufactured in a facility that is not registered by the FDA. | 2,868 kits | 2020-11-25 |
| 2020-04-13 | Class II | Process control | The surgical gowns were manufactured in a facility that is not registered by the FDA. | 2,868 surgical 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.