BodyGuard® Microset With Needleless Y-Site
150 in. (380 cm) For Use with the BodyGuard® Infusion Pump
49manufacturers in China registered for this device type
2catalogue numbers in this listing
38recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | CME America, LLC |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K042696 |
| Record published | 2017-06-15 |
| Record revised | 2020-11-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, case of 12 |
| Distribution end date | 2020-10-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A120-003XYVA | Withdrawn | |
| A120-003XYVA | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
Recalls Naming This Product
38 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 3250 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 479559 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 178057 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 140565 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 345244 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 273700 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 1273892 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 146 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 50 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 25746 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 18520 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 95110 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 291386 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 5000 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 198160 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 402026 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 25286 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 500 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 16850 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 55455 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 390230 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 28600 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 169856 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 31484 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 29720 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 113482 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 4234 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 50122 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 8016 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 7200 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 6320 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 6016 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 36286 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 13280 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 1824 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 50 | 2022-05-09 |
| CME America, LLC | 510(k) number | 2020-06-16 | Class I | Device Design | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy | 152570 | 2022-05-09 |
| CME America, LLC | UDI-DI | 2019-09-16 | Class I | Nonconforming Material/Component | When using a specific tubing set with infusion pump system, may result in under deliver of fluids. | 69400 infusion sets | 2022-04-13 |
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 | Closed |
|---|---|---|---|---|---|
| 2020-01-14 | Class II | Process control | The filter installed onto the tube set may have the incorrect pore size. | 5,800 infusion sets from lot 90829 and 24,500 from lot 16201 | 2021-05-27 |
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.