ACS
Pack Breast Reconstruction LH - 2076594
2manufacturers in China registered for this device type
109catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | FTN |
| Device type | Plastic Surgery And Accessories Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3925 |
| Premarket notification | Exempt |
| Record published | 2020-02-14 |
| 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 |
|---|---|---|
| LSRLHBREASTA | In distribution | |
| UIPS31F | In distribution | |
| SHPS27D | In distribution | |
| BBPL20D | In distribution | |
| OSBR15C | In distribution | |
| CCBR56A | In distribution | |
| PEPP14Z | In distribution | |
| LMPL56K | In distribution | |
| AGPP38I | In distribution | |
| PCPL36D | In distribution | |
| SWBA26G | In distribution | |
| BUPL88F | In distribution | |
| MTBI12A | In distribution | |
| PEPP14AB | In distribution | |
| WVPL36D | In distribution | |
| FABR35J | In distribution | |
| CCBR56I | In distribution | |
| MTPL16C | In distribution | |
| PEPP14AD | In distribution | |
| SWBA26I | In distribution | |
| AGPP38L | In distribution | |
| UTBR74U | In distribution | |
| LSRLHBREASTB | In distribution | |
| MTPL15A | In distribution | |
| UIPS31L | In distribution | |
| VGPL88B | In distribution | |
| UIPS31E | In distribution | |
| UIPS10B | In distribution | |
| PEPP14AC | In distribution | |
| LLPL31E | In distribution | |
| FABR35M | In distribution | |
| PCPL36I | In distribution | |
| LSRLHBREASTC | In distribution | |
| SJPI42H | In distribution | |
| CCBR56H | In distribution | |
| LMPL56L | In distribution | |
| LMPL56N | In distribution | |
| PEPP14AE | In distribution | |
| MTPL16A | In distribution | |
| WPMP16I | In distribution | |
| PEPP14AA | In distribution | |
| MTPL16D | In distribution | |
| CCBR56D | In distribution | |
| SWBA26H | In distribution | |
| LLMS45G | In distribution | |
| HHBR20D | In distribution | |
| UIPS31K | In distribution | |
| SJPI42F | In distribution | |
| AGPP38J | In distribution | |
| SJPI42I | In distribution | |
| FABR35K | In distribution | |
| CCBR56E | In distribution | |
| UIPS31G | In distribution | |
| PCPL36A | In distribution | |
| UIPS10A | In distribution | |
| AGPP38M | In distribution | |
| FABR35N | In distribution | |
| MTPL16B | In distribution | |
| IAPL49A | In distribution | |
| FABR35O | In distribution | |
| AGPP38K | In distribution | |
| UTBR74T | In distribution | |
| UIPS31H | In distribution | |
| SJPI42G | In distribution | |
| IAPL49B | In distribution | |
| OSBR15D | In distribution | |
| OSBR15B | In distribution | |
| WVPL36F | In distribution | |
| SHPS27E | In distribution | |
| HHBR20B | In distribution | |
| PCPL36B | In distribution | |
| BUPL88E | In distribution | |
| LLMS45I | In distribution | |
| WVPL36E | In distribution | |
| LLMS45H | In distribution | |
| CBPL11C | In distribution | |
| LLPL31D | In distribution | |
| HHBR20C | In distribution | |
| LSROSCMASTE | In distribution | |
| UIPS31N | In distribution | |
| MTFC76A | In distribution | |
| CCBR56G | In distribution | |
| MHPA02C | In distribution | |
| UIPS31M | In distribution | |
| LAMP04AC | In distribution | |
| LSROSCMASTD | In distribution | |
| CCBR56F | In distribution | |
| LMPL56P | In distribution | |
| LSROSCMASTC | In distribution | |
| PCPL36E | In distribution | |
| PCPL36J | In distribution | |
| UIPS31J | In distribution | |
| FABR35H | In distribution | |
| BPMM62B | In distribution | |
| CCBR56C | In distribution | |
| LAMP04AA | In distribution | |
| OSBR15E | In distribution | |
| LSROSCMASTB | In distribution | |
| PCPL36H | In distribution | |
| SWBA26J | In distribution | |
| PCPL36G | In distribution | |
| SLDP19A | In distribution | |
| MTPL14A | In distribution | |
| CCBR56J | In distribution | |
| VGPL88A | In distribution | |
| UIBR42D | In distribution | |
| LAMP04AB | In distribution | |
| UIPS10C | In distribution | |
| BPMM62A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 4,366 |
| Stradis | Stradis Healthcare | 102 |
| Henry Schein | Henry Schein, Inc. | 93 |
| Stradis Healthcare | Stradis Healthcare | 81 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 20 |
| Regard™ | ROi CPS LLC | 13 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 12 |
| Medline | Medline Industries, Inc. | 5 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 5 |
| Stradis Medical, LLC. | Stradis Healthcare | 5 |
| Invenio | GRI-Alleset, Inc. | 3 |
| Bausch and Lomb | Medline Industries, Inc. | 3 |
Showing 12 of 19. All products under Plastic Surgery And Accessories Kit
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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 | 20 cases |
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 | Closed |
|---|---|---|---|---|---|
| 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 | 112 units | |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 1 unit | |
| 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.