Jamshidi
Jamshidi Menghini Soft Tissue Biopsy Tray - 15 G x 100 mm Needle/Syringe with Centimeter Depth Markings
1manufacturer
13catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | FSH |
| Device type | Tray, Surgical, Needle |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-30 |
| Record revised | 2023-08-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 10 |
| Sizes | Needle gauge 15 to 17 G; length 70 to 100 mm; length 2 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SK7017A | Needle Gauge 17 G | In distribution |
| SK7016A | Needle Gauge 16 G | In distribution |
| SK1015A | Needle Gauge 15 G | In distribution |
| SK1017A | Needle Gauge 17 G | In distribution |
| SK1016A | Needle Gauge 16 G | In distribution |
| SN7015X | Length 70 mm | In distribution |
| SN1015X | Length 100 mm | In distribution |
| SN7017X | Length 70 mm | In distribution |
| SN1016X | Needle Gauge 16 G | In distribution |
| SN1017X | Length 100 mm | In distribution |
| SK7015A | Length 70 mm | In distribution |
| SN7016X | Needle Gauge 16 G | In distribution |
| BEK2015 | Length 2 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tray, Surgical, Needle | Carefusion 2200, Inc. | 6 |
| Inhance | Depuy (Ireland) | 2 |
| Inhance Intact | Depuy (Ireland) | 1 |
| Medline Industries, Inc. | Medline Industries, Inc. | 1 |
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 |
|---|---|---|---|---|---|
| 2017-02-23 | Class II | Package design/selection | The integrity of the sterile packaging is potentially compromised. | a.) 13,010 units b.) 2116 units | 2019-07-09 |
| 2017-02-23 | Class II | Package design/selection | The integrity of the sterile packaging is potentially compromised. | 1200 units | 2019-07-09 |
| 2017-02-23 | Class II | Package design/selection | The integrity of the sterile packaging is potentially compromised. | 2019-07-09 | |
| 2017-02-23 | Class II | Package design/selection | The integrity of the sterile packaging is potentially compromised. | 790 units | 2019-07-09 |
| 2017-02-23 | Class II | Package design/selection | The integrity of the sterile packaging is potentially compromised. | 14,200 units | 2019-07-09 |
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.