ACS
DTC Biopsy Breast Pack (PS 209461)
2manufacturers in China registered for this device type
86catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | FCH |
| Device type | Tray, Biopsy, Without Biopsy Instruments |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Premarket notification | Exempt |
| Record published | 2022-08-25 |
| 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 |
|---|---|---|
| BLSB90J | In distribution | |
| SADI48A | In distribution | |
| LLBB20D | In distribution | |
| SLIM21F | In distribution | |
| BLBT99H | In distribution | |
| MEBP17I | In distribution | |
| LLBP44D | In distribution | |
| MMBP01I | In distribution | |
| MCBP83C | In distribution | |
| MEBP17H | In distribution | |
| NMBP44L | In distribution | |
| AHBP12A | In distribution | |
| CXBT11E | In distribution | |
| BMBI48F | In distribution | |
| SLIM21G | In distribution | |
| SWBB52E | In distribution | |
| SNBI78I | In distribution | |
| BPIB18B | In distribution | |
| MMBP72F | In distribution | |
| LLBB20C | In distribution | |
| MMBP72A | In distribution | |
| BLBT99J | In distribution | |
| BLSB90K | In distribution | |
| LSRLMBIOB | In distribution | |
| SLGT78L | In distribution | |
| MEBP17K | In distribution | |
| SLGT78K | In distribution | |
| NCBI91F | In distribution | |
| NMBP44K | In distribution | |
| SFBP60S | In distribution | |
| LLBB20B | In distribution | |
| CXBB12C | In distribution | |
| MMBP72E | In distribution | |
| MDDB41B | In distribution | |
| MEBP17J | In distribution | |
| SFBP60R | In distribution | |
| SWBB52F | In distribution | |
| NCBI91G | In distribution | |
| SLGT78J | In distribution | |
| CXBB12D | In distribution | |
| MRBC17J | In distribution | |
| SNBI78E | In distribution | |
| SLIM21E | In distribution | |
| SNBI78G | In distribution | |
| LLMB22E | In distribution | |
| UMIN68B | In distribution | |
| CXBT11C | In distribution | |
| BLBT99I | In distribution | |
| MCBP83B | In distribution | |
| CXBT11G | In distribution | |
| LLBP44C | In distribution | |
| EFBP23A | In distribution | |
| BPIB18A | In distribution | |
| UMIN68E | In distribution | |
| LLBB20E | In distribution | |
| MCBP83E | In distribution | |
| CDBI93E | In distribution | |
| SLIM21H | In distribution | |
| BLSB90I | In distribution | |
| EFBP10A | In distribution | |
| MCBP83D | In distribution | |
| RWBI43H | In distribution | |
| EVPB38A | In distribution | |
| RWBI43F | In distribution | |
| CXBT11D | In distribution | |
| BMBI48E | In distribution | |
| MMBP72C | In distribution | |
| BEHL09E | In distribution | |
| SWBB52G | In distribution | |
| LSRLMBIOC | In distribution | |
| MCBP83A | In distribution | |
| SLIM21I | In distribution | |
| MDDB41A | In distribution | |
| LSRBIOPSYC | In distribution | |
| SNBI78F | In distribution | |
| SWBB52H | In distribution | |
| UMIN68C | In distribution | |
| RWBI43G | In distribution | |
| MMBP72B | In distribution | |
| MIBB39A | In distribution | |
| TNBP03M | In distribution | |
| BLBT99G | In distribution | |
| SNBI78H | In distribution | |
| AHBP12B | In distribution | |
| CXBT11F | In distribution | |
| EFBP10B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diversatek Healthcare | Diversatek Healthcare Inc | 65 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| Therapak | Therapak, LLC | 12 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 5 |
| Medichoice | Owens & Minor Distribution, Inc. | 1 |
| CleanFreak® | Diversatek Healthcare Inc | 1 |
| Halyard | Avid Medical, Inc. | 1 |
Recalls Naming This Product
2 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 | 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 | 224 |
| 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 | 95 units |
Recalls
1 of these is 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 |
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.