ACS
Pack Vaginal Delivery Smhs - 2068301
1manufacturer
244catalogue numbers in this listing
10recalls 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 | MLS |
| Device type | Labor And Delivery Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| 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 |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LSRCFHVAGDC | In distribution | |
| UPVD01J | In distribution | |
| UPVD01I | In distribution | |
| AGOB35I | In distribution | |
| MEVG08Q | In distribution | |
| LBOB11A | In distribution | |
| LLBN11A | In distribution | |
| JOOB63A | In distribution | |
| LAOB30X | In distribution | |
| HGVD36H | In distribution | |
| BLOB27I | In distribution | |
| FHVD34Q | In distribution | |
| GBDV49C | In distribution | |
| MMOB57C | In distribution | |
| ALDV39A | In distribution | |
| SPOB12F | In distribution | |
| AHOB38P | In distribution | |
| CILA59H | In distribution | |
| SLED01A | In distribution | |
| BRVG05K | In distribution | |
| RCOB11B | In distribution | |
| PLBI50H | In distribution | |
| SAOB88W | In distribution | |
| SLVD11K | In distribution | |
| LSROBDELIVD | In distribution | |
| EVBH28D | In distribution | |
| MEVG08S | In distribution | |
| HSLA72J | In distribution | |
| WLVD02A | In distribution | |
| LLLD64J | In distribution | |
| BRVG05N | In distribution | |
| PLBI50I | In distribution | |
| HSLA72Q | In distribution | |
| SLOB77H | In distribution | |
| AHOB38Q | In distribution | |
| LLLD64I | In distribution | |
| GILA96D | In distribution | |
| FHVD34R | In distribution | |
| SGDV22F | In distribution | |
| FHVD34P | In distribution | |
| SGDV22B | In distribution | |
| BRVG05O | In distribution | |
| LSROBDELIVC | In distribution | |
| EVBH28B | In distribution | |
| RCOB11C | In distribution | |
| HSLA72O | In distribution | |
| MHLD95Q | In distribution | |
| BHDM27F | In distribution | |
| LAOB30W | In distribution | |
| MHLD95T | In distribution | |
| LALD87E | In distribution | |
| SJVD14F | In distribution | |
| AKDV96B | In distribution | |
| SMOB41B | In distribution | |
| SHVA68F | In distribution | |
| CEDL04H | In distribution | |
| LKVG10M | In distribution | |
| MEVG08O | In distribution | |
| SGDV22D | In distribution | |
| WEVD55D | In distribution | |
| EHDV12B | In distribution | |
| LLLD64K | In distribution | |
| MHLD95R | In distribution | |
| LAOB30Y | In distribution | |
| MMOB57A | In distribution | |
| LLBN11B | In distribution | |
| ACDV16C | In distribution | |
| RCVG19B | In distribution | |
| MSLD49A | In distribution | |
| SHVA68G | In distribution | |
| CXVG81Q | In distribution | |
| HOVG60E | In distribution | |
| CXVG81R | In distribution | |
| LAOB30AA | In distribution | |
| HSLA72R | In distribution | |
| HGVD36I | In distribution | |
| RWOB72H | In distribution | |
| CEDL04K | In distribution | |
| SLHS01B | In distribution | |
| HGVD36F | In distribution | |
| SLUD23A | In distribution | |
| CEDL04J | In distribution | |
| BHDM27E | In distribution | |
| HILD52F | In distribution | |
| HOVG60B | In distribution | |
| RCOB11E | In distribution | |
| WHOB61C | In distribution | |
| RCOB11A | In distribution | |
| SMOB41C | In distribution | |
| SLNA01A | In distribution | |
| LSRVAGDELIVC | In distribution | |
| RCVG19C | In distribution | |
| CXVG81O | In distribution | |
| AGOB35F | In distribution | |
| RCVG19A | In distribution | |
| UPVD01G | In distribution | |
| LALD87G | In distribution | |
| PLBI50J | In distribution | |
| PLBI50K | In distribution | |
| BHDM27D | In distribution | |
| SLOB77I | In distribution | |
| MEVG08R | In distribution | |
| HGVD36G | In distribution | |
| LSRMOMBABYG | In distribution | |
| BLOB27K | In distribution | |
| HSLA72N | In distribution | |
| SAOB88Y | In distribution | |
| CXVG81P | In distribution | |
| HSLA72I | In distribution | |
| LSRMOMBABYF | In distribution | |
| LAOB30Z | In distribution | |
| ACDV16A | In distribution | |
| HOVG60C | In distribution | |
| GBDV49E | In distribution | |
| AGOB35G | In distribution | |
| WEVD55C | In distribution | |
| ALDV39C | In distribution | |
| OSVG26C | In distribution | |
| LALD87C | In distribution | |
| LLLD64M | In distribution | |
| SPOB12G | In distribution | |
| HILD52I | In distribution | |
| SLOB77F | In distribution | |
| HSLA72P | In distribution | |
| MMOB57B | In distribution | |
| WHVD02E | In distribution | |
| SHVA68E | In distribution | |
| MSMT46A | In distribution | |
| BRVG05M | In distribution | |
| ASDV25C | In distribution | |
| AGOB35E | In distribution | |
| HGVD36C | In distribution | |
| GBDV49D | In distribution | |
| SAOB88X | In distribution | |
| SLOB77G | In distribution | |
| LLLD64L | In distribution | |
| OSVG26B | In distribution | |
| HSLA72L | In distribution | |
| SGDV22A | In distribution | |
| MTUM30A | In distribution | |
| AHLD15S | In distribution | |
| MCDP22A | In distribution | |
| CXVG81S | In distribution | |
| PLBI50E | In distribution | |
| UILD70K | In distribution | |
| MEVG08P | In distribution | |
| RWOB72J | In distribution | |
| ASMT11A | In distribution | |
| MHLD95U | In distribution | |
| SVBB64C | In distribution | |
| AHLD15Y | In distribution | |
| BLOB27N | In distribution | |
| LLLD64N | In distribution | |
| LLLD64H | In distribution | |
| AKMT92A | In distribution | |
| RWOB72I | In distribution | |
| RCOB11D | In distribution | |
| MHLD95P | In distribution | |
| HSLA72H | In distribution | |
| SVBB64B | In distribution | |
| SMOB41D | In distribution | |
| JNVD34A | In distribution | |
| UILD70I | In distribution | |
| HILD52H | In distribution | |
| SAOB88Z | In distribution | |
| EVBH28C | In distribution | |
| AHLD15T | In distribution | |
| HSLA72M | In distribution | |
| JOOB63C | In distribution | |
| LLLD64O | In distribution | |
| MHLD95S | In distribution | |
| ACDV16B | In distribution | |
| BLOB27M | In distribution | |
| SGDV22E | In distribution | |
| AHOB38O | In distribution | |
| ALDV39B | In distribution | |
| LLLD19G | In distribution | |
| LLLD19H | In distribution | |
| AHLD15X | In distribution | |
| UPVD01K | In distribution | |
| LLLD19E | In distribution | |
| SHVA68D | In distribution | |
| BDDV89A | In distribution | |
| PLBI50F | In distribution | |
| AHLD15U | In distribution | |
| PLBI50D | In distribution | |
| UPVD01F | In distribution | |
| MMOB57D | In distribution | |
| LALD87F | In distribution | |
| HGVD36E | In distribution | |
| CEDL04I | In distribution | |
| SAVA89G | In distribution | |
| LSROBDELIVE | In distribution | |
| HGVD36J | In distribution | |
| LLLD19I | In distribution | |
| UILD70F | In distribution | |
| LLBN11C | In distribution | |
| SMOB41E | In distribution | |
| SGDV22C | In distribution | |
| LLLD19F | In distribution | |
| CEDL04G | In distribution | |
| ASDV25A | In distribution | |
| CEDL04M | In distribution | |
| AHLD15W | In distribution | |
| AHLD15V | In distribution | |
| SAVA89F | In distribution | |
| AKDV96A | In distribution | |
| PLBI50G | In distribution | |
| BLOB27J | In distribution | |
| JOOB63B | In distribution | |
| UILD70G | In distribution | |
| WBVD47E | In distribution | |
| BHDM27C | In distribution | |
| HILD52E | In distribution | |
| HGVD36D | In distribution | |
| CEDL04N | In distribution | |
| WNLD12I | In distribution | |
| LLLD64F | In distribution | |
| BRVG05P | In distribution | |
| LLLD64G | In distribution | |
| LLLD64E | In distribution | |
| LKVG10N | In distribution | |
| AGOB35C | In distribution | |
| SHVA68H | In distribution | |
| LSRMOMBABYD | In distribution | |
| EHDV12A | In distribution | |
| AGOB35H | In distribution | |
| ASDV25B | In distribution | |
| NLOB38B | In distribution | |
| AHOB38R | In distribution | |
| WEVD55B | In distribution | |
| CEDL04L | In distribution | |
| HILD52J | In distribution | |
| AGOB35D | In distribution | |
| MTDV68A | In distribution | |
| AKNB64A | In distribution | |
| MMOB57F | In distribution | |
| AHOB38N | In distribution | |
| LALD87I | In distribution | |
| ANNK98H | In distribution | |
| UILD70J | In distribution | |
| MTDV68B | In distribution | |
| HILD52G | In distribution | |
| AHOB38M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 3,909 |
| Medline Industries, Inc. | Medline Industries, Inc. | 3,405 |
| Centurion | Centurion Medical Products Corporation | 159 |
| Regard™ | ROi CPS LLC | 125 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 63 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 29 |
| Aligned Medical Solutions | Aligned Medical Solutions | 16 |
| Medical Action Industries | Medical Action Industries, Inc. | 11 |
| Medline | Medline Industries, Inc. | 6 |
| Halyard | Avid Medical, Inc. | 6 |
| Devon | Cardinal Health | 4 |
| Instrapac | Robinson Healthcare Limited | 4 |
Showing 12 of 16. All products under Labor And Delivery Kit
Recalls Naming This Product
7 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 | 781 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. | 725 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. | 1836 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. | 36 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. | 360 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. | 1 unit |
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 |
|---|---|---|---|---|
| 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 | 114 units |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 15 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.