ACS
Sterile Lube Jelly Bulb Syringe - 243381
1manufacturer
938catalogue numbers in this listing
13recalls 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 | OJG |
| Device type | Neurological Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4525 |
| Premarket notification | Exempt |
| Record published | 2022-03-21 |
| Record revised | 2022-06-17 (version 6) |
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 | 2024-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ANCP30AK | In distribution | |
| UISH55I | In distribution | |
| UICR10S | In distribution | |
| UICR33AQ | In distribution | |
| UISH15AM | In distribution | |
| RBLM14N | In distribution | |
| BHCR54F | In distribution | |
| MPCR42K | In distribution | |
| RCDI27B | In distribution | |
| MHCP75AA | In distribution | |
| MPSP90J | In distribution | |
| HHCR47D | In distribution | |
| SLCR80L | In distribution | |
| MHHN60D | In distribution | |
| MCSP92B | In distribution | |
| IHNE35AN | In distribution | |
| WPLA17J | In distribution | |
| MPLN54F | In distribution | |
| LANE15L | In distribution | |
| MENE06S | In distribution | |
| MTCR00C | In distribution | |
| UICR10Q | In distribution | |
| RBLM14M | In distribution | |
| ANCP30AG | In distribution | |
| FHNE25AD | In distribution | |
| ANPP15AO | In distribution | |
| FRSP50Q | In distribution | |
| FRSP50O | In distribution | |
| AGBA20H | In distribution | |
| UILM77AS | In distribution | |
| AHCR00F | In distribution | |
| UHSP33Y | In distribution | |
| MPNV28H | In distribution | |
| UICR33AZ | In distribution | |
| BPCR13D | In distribution | |
| AGLA17U | In distribution | |
| MPSP90I | In distribution | |
| WENI56J | In distribution | |
| WENE21J | In distribution | |
| MPCR42J | In distribution | |
| BHCR22N | In distribution | |
| HHCR47B | In distribution | |
| AHAC71D | In distribution | |
| LMCR43Z | In distribution | |
| EVCR12B | In distribution | |
| FILM04S | In distribution | |
| UILM77AP | In distribution | |
| WHCE21C | In distribution | |
| HNFB01A | In distribution | |
| GBSP29C | In distribution | |
| FHNE25AA | In distribution | |
| SLBA46G | In distribution | |
| MHSO02F | In distribution | |
| SHLU12H | In distribution | |
| UICR33AY | In distribution | |
| SLCR80H | In distribution | |
| SSSP83F | In distribution | |
| FRSP50T | In distribution | |
| MCSP61H | In distribution | |
| AKSP93C | In distribution | |
| UTSL72AA | In distribution | |
| AHLM17D | In distribution | |
| CBAC47E | In distribution | |
| HOSP20I | In distribution | |
| ESCR92B | In distribution | |
| BPVP85A | In distribution | |
| NCCR18J | In distribution | |
| WENE21L | In distribution | |
| OSSP27D | In distribution | |
| SLNA12F | In distribution | |
| AGSB96M | In distribution | |
| BDSP90A | In distribution | |
| CCMT15C | In distribution | |
| UISH15AS | In distribution | |
| MMCR11L | In distribution | |
| AGNE20K | In distribution | |
| UMNE19C | In distribution | |
| UINR44O | In distribution | |
| SANE27R | In distribution | |
| MMCR10Q | In distribution | |
| AHCR00G | In distribution | |
| TOPS11E | In distribution | |
| AGDB14K | In distribution | |
| RBLM14O | In distribution | |
| CCSP18A | In distribution | |
| UILM77AO | In distribution | |
| MHHD46X | In distribution | |
| EVCR12A | In distribution | |
| MPSP90K | In distribution | |
| IHNE35AJ | In distribution | |
| SANE27N | In distribution | |
| MMNS20F | In distribution | |
| WENI56I | In distribution | |
| AGNE20L | In distribution | |
| LOSC15A | In distribution | |
| SSSP83G | In distribution | |
| OSCR20B | In distribution | |
| UHSP33AA | In distribution | |
| LLCT45K | In distribution | |
| MPLN54I | In distribution | |
| WENI56B | In distribution | |
| UICR33AR | In distribution | |
| MHCP75AC | In distribution | |
| LSRLMNEINTC | In distribution | |
| WENE21B | In distribution | |
| EVLM13C | In distribution | |
| SLCN72G | In distribution | |
| UILM77AU | In distribution | |
| AHCR93D | In distribution | |
| JOSP18C | In distribution | |
| MHCP75AE | In distribution | |
| MTNE44B | In distribution | |
| MMCR10P | In distribution | |
| HJCR52F | In distribution | |
| NLNE61A | In distribution | |
| CCHN24C | In distribution | |
| WECR41B | In distribution | |
| BLNE76K | In distribution | |
| TNNE17AB | In distribution | |
| UINE17R | In distribution | |
| AGSB00N | In distribution | |
| RWSP17G | In distribution | |
| BHCR22P | In distribution | |
| BPCR13A | In distribution | |
| GBSP29G | In distribution | |
| BLNE76N | In distribution | |
| EVLM13B | In distribution | |
| AHCR92E | In distribution | |
| MMCR11C | In distribution | |
| MCSP92A | In distribution | |
| ANLM40AD | In distribution | |
| UICR10I | In distribution | |
| WENI56D | In distribution | |
| SLCR94H | In distribution | |
| CXCN94Z | In distribution | |
| BHCR54E | In distribution | |
| EVLF56F | In distribution | |
| OSSP27E | In distribution | |
| EFCR86B | In distribution | |
| MHNE31I | In distribution | |
| LLLC26G | In distribution | |
| MPSP90F | In distribution | |
| MMCR11E | In distribution | |
| UIMP71T | In distribution | |
| PWNP56R | In distribution | |
| LLCT45F | In distribution | |
| TNSF40K | In distribution | |
| TPSS31C | In distribution | |
| UDCP57AH | In distribution | |
| MMNS20E | In distribution | |
| COSP51I | In distribution | |
| MPST85A | In distribution | |
| AHAC71A | In distribution | |
| MPCR42H | In distribution | |
| CCSP18E | In distribution | |
| CCSF45A | In distribution | |
| IHNE35AF | In distribution | |
| CCHN24D | In distribution | |
| WENI56F | In distribution | |
| JCSP60F | In distribution | |
| UISH55H | In distribution | |
| ESLM19A | In distribution | |
| UMNE19E | In distribution | |
| HJNE97H | In distribution | |
| FBLC19A | In distribution | |
| LKOR13W | In distribution | |
| MHHD46W | In distribution | |
| PRNA38A | In distribution | |
| LLCR99G | In distribution | |
| MMNS20H | In distribution | |
| LSRLMNEUROI | In distribution | |
| ANCI17AJ | In distribution | |
| ANCP30AE | In distribution | |
| AGDB14L | In distribution | |
| AHCR00B | In distribution | |
| LLLM16K | In distribution | |
| UIMP71W | In distribution | |
| DVSP33B | In distribution | |
| CENR14K | In distribution | |
| SHLU12K | In distribution | |
| SLCR80G | In distribution | |
| ISLD70H | In distribution | |
| UDLM94V | In distribution | |
| SFLM54AA | In distribution | |
| CCMD35B | In distribution | |
| WHLL20F | In distribution | |
| CCAP12C | In distribution | |
| UILM77AM | In distribution | |
| LANE15M | In distribution | |
| NCAC96L | In distribution | |
| HSLM53U | In distribution | |
| LLCT45J | In distribution | |
| SLCN72D | In distribution | |
| LANE15K | In distribution | |
| SLCN72H | In distribution | |
| LSRSWRSPND | In distribution | |
| LLLM16L | In distribution | |
| ANAP22AO | In distribution | |
| MTSP87B | In distribution | |
| SLNA12E | In distribution | |
| JOSP18G | In distribution | |
| BHNE27N | In distribution | |
| BHCR22M | In distribution | |
| FRSP50P | In distribution | |
| UILM77AV | In distribution | |
| MCSP61G | In distribution | |
| SHLU12J | In distribution | |
| UINR44M | In distribution | |
| BLLM39J | In distribution | |
| SFTR00H | In distribution | |
| CXCN94AC | In distribution | |
| ANPP15AR | In distribution | |
| ALBK51C | In distribution | |
| MENE06Q | In distribution | |
| UICR33AT | In distribution | |
| ANPP15AQ | In distribution | |
| EFSP30D | In distribution | |
| CCHN24G | In distribution | |
| OSCR20H | In distribution | |
| CCSP18D | In distribution | |
| HJNE97G | In distribution | |
| OSSP27F | In distribution | |
| ACNE73B | In distribution | |
| TPSP14C | In distribution | |
| RCNA47B | In distribution | |
| BHLA24K | In distribution | |
| UISH55U | In distribution | |
| UISH15AT | In distribution | |
| ANAP22AN | In distribution | |
| SFLM54X | In distribution | |
| LKCR11AB | In distribution | |
| DVSP33E | In distribution | |
| ALBK51D | In distribution | |
| UISH55W | In distribution | |
| DVSP33C | In distribution | |
| MHHD46Z | In distribution | |
| UISH55O | In distribution | |
| EVNE25B | In distribution | |
| ANAN51AI | In distribution | |
| RWCR92G | In distribution | |
| UINE17S | In distribution | |
| LSRVPSHUNTC | In distribution | |
| UINR44N | In distribution | |
| SHCR60G | In distribution | |
| FHNE25Y | In distribution | |
| WECR41E | In distribution | |
| GBSP29E | In distribution | |
| ANPP15AM | In distribution | |
| SLCR80J | In distribution | |
| BPNR24A | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 25,194 |
| Medline Industries, Inc. | Medline Industries, Inc. | 3,084 |
| Avid TruCustom | Avid Medical, Inc. | 969 |
| Halyard | Avid Medical, Inc. | 718 |
| Regard™ | ROi CPS LLC | 208 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 55 |
| Aligned Medical Solutions | Aligned Medical Solutions | 53 |
| V. Mueller | Steris Corporation | 27 |
| Nico BrainPath Approach | Nico Corporation | 25 |
| V. Mueller | Carefusion 2200, Inc. | 13 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 11 |
| Phasor | Phasor Health, LLC | 8 |
Showing 12 of 24. All products under Neurological Tray
Recalls Naming This Product
8 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 | 204 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. | 170 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. | 120 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. | 106 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 | 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 | 3 |
| 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 | 2717 units |
| American Contract Systems, Inc. | UDI-DI | 2022-03-22 | Class II | Process control | Product was sterilized with a higher than specification EO concentration. | 72 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 |
|---|---|---|---|---|---|
| 2026-05-19 | Class II | Nonconforming Material/Component | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin le | 4789 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 | |
| 2025-02-04 | Class II | Device Design | During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures. | 91 units | |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 37 units | |
| 2020-04-13 | Class II | Process control | The surgical gowns were manufactured in a facility that is not registered by the FDA. | 2868 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.