Cook Spectrum Turbo-Ject
Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter
5manufacturers in China registered for this device type
73catalogue numbers in this listing
9510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2022-02-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2022-02-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G52930 | In distribution | |
| G23709 | In distribution | |
| G50744 | In distribution | |
| G03810 | In distribution | |
| G54908 | In distribution | |
| G18232 | In distribution | |
| G03811 | In distribution | |
| G50745 | In distribution | |
| G23710 | In distribution | |
| G03813 | In distribution | |
| G50746 | In distribution | |
| G34566 | In distribution | |
| G34561 | In distribution | |
| G23917 | In distribution | |
| G50747 | In distribution | |
| G34563 | In distribution | |
| G23915 | In distribution | |
| G03807 | In distribution | |
| G03803 | In distribution | |
| G34558 | In distribution | |
| G34546 | In distribution | |
| G50740 | In distribution | |
| G56192 | In distribution | |
| G34557 | In distribution | |
| G34565 | In distribution | |
| G23708 | In distribution | |
| G34554 | In distribution | |
| G23943 | In distribution | |
| G18234 | In distribution | |
| G23932 | In distribution | |
| G34564 | In distribution | |
| G23910 | In distribution | |
| G50743 | In distribution | |
| G54481 | In distribution | |
| G34549 | In distribution | |
| G50748 | In distribution | |
| G34559 | In distribution | |
| G50741 | In distribution | |
| G34556 | In distribution | |
| G34560 | In distribution | |
| G03805 | In distribution | |
| G50742 | In distribution | |
| G03814 | In distribution | |
| G34562 | In distribution | |
| G56200 | Withdrawn | |
| G34550 | Withdrawn | |
| G34552 | Withdrawn | |
| G23911 | Withdrawn | |
| G23907 | Withdrawn | |
| G03812 | Withdrawn | |
| G56198 | Withdrawn | |
| G23913 | Withdrawn | |
| G34545 | Withdrawn | |
| G23916 | Withdrawn | |
| G34551 | Withdrawn | |
| G34547 | Withdrawn | |
| G54479 | Withdrawn | |
| G54480 | Withdrawn | |
| G23908 | Withdrawn | |
| G03806 | Withdrawn | |
| G23707 | Withdrawn | |
| G54478 | Withdrawn | |
| G23912 | Withdrawn | |
| G34553 | Withdrawn | |
| G05673 | Withdrawn | |
| G34548 | Withdrawn | |
| G23711 | Withdrawn | |
| G56193 | Withdrawn | |
| G23909 | Withdrawn | |
| G23914 | Withdrawn | |
| G03804 | Withdrawn | |
| G05676 | Withdrawn | |
| G34555 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
| Vygon | Vygon Corp. | 50 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171994 | 2018-02-22 |
| K161496 | 2016-10-07 |
| K133634 | 2013-12-23 |
| K132885 | 2013-10-11 |
| K132334 | 2013-08-16 |
| K111244 | 2011-06-14 |
| K072625 | 2007-12-13 |
| K041849 | 2005-07-21 |
| K851243 | 1986-03-14 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
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.