# Jiangsu Caina Medical Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Jiangsu Caina Medical Co., Ltd · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Safety Push Button Blood Collection Set | O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Safelock Disposable Insulin Syringe | Disposable Insulin Syringe | Syringes; With or without Needles | Hard pack syringe | Disposable Insulin Syringe | Hard pack syringe | Disposable Insulin Pen Needle | Safety Insulin Pen Needle | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Syringes; With or without Needles | Safety Push Button Blood Collection Set | Safelock Disposable Blood Collection Set; Disposable Blood Collection Set | Disposable Infusion Needle; Safelock Disposable Infusion Needle | Vented Vial Transfer Pin | Safelock Disposable Insulin Syringe | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Pre filled Syringe with Saline; product code is 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection | 78 P - - NR Enteral Syringes with enteral specific connectors | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 L - - HI Set, I.V. Fluid Transer | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 N - - GT Device, Flush, Vascular Access; date published is 05/08/2026; address is No. 23 Huanxi Road , Zhutangzhen Jiangyin , Wuxi, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** Jiangsu Caina Medical Co., Ltd _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** No. 23 Huanxi Road , Zhutangzhen Jiangyin , Wuxi, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 05/08/2026 _(verified: appears in the quote below)_
- **Product code:** 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection | 78 P - - NR Enteral Syringes with enteral specific connectors | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 L - - HI Set, I.V. Fluid Transer | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 N - - GT Device, Flush, Vascular Access _(verified: each item appears in the quote below)_
- **Product:** Safety Push Button Blood Collection Set | O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Safelock Disposable Insulin Syringe | Disposable Insulin Syringe | Syringes; With or without Needles | Hard pack syringe | Disposable Insulin Syringe | Hard pack syringe | Disposable Insulin Pen Needle | Safety Insulin Pen Needle | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Syringes; With or without Needles | Safety Push Button Blood Collection Set | Safelock Disposable Blood Collection Set; Disposable Blood Collection Set | Disposable Infusion Needle; Safelock Disposable Infusion Needle | Vented Vial Transfer Pin | Safelock Disposable Insulin Syringe | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Pre filled Syringe with Saline _(verified: each item appears in the quote below)_
- **FDA notes:** Safety Push Button Blood Collection Set | O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Safelock Disposable Insulin Syringe | Disposable Insulin Syringe | Syringes; With or without Needles | Hard pack syringe >>declaring K141359<<< | Disposable Insulin Syringe | Hard pack syringe >>declaring K141359<<< | Disposable Insulin Pen Needle | Safety Insulin Pen Needle | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Syringes; With or without Needles | Safety Push Button Blood Collection Set | Safelock Disposable Blood Collection Set; Disposable Blood Collection Set | Disposable Infusion Needle; Safelock Disposable Infusion Needle | Vented Vial Transfer Pin | Safelock Disposable Insulin Syringe | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Pre filled Syringe with Saline _(verified: each item appears in the quote below)_

## What the source says

> Jiangsu Caina Medical Co., Ltd Date Published : 05/08/2026 No. 23 Huanxi Road , Zhutangzhen Jiangyin , Wuxi, Jiangsu CHINA 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection Date Published: 05/08/2026 Desc: Safety Push Button Blood Collection Set Notes: Safety Push Button Blood Collection Set 78 P - - NR Enteral Syringes with enteral specific connectors Date Published: 05/08/2026 Desc: O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) Notes: O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle Notes: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Safelock Disposable Insulin Syringe Notes: Safelock Disposable Insulin Syringe 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Disposable Insulin Syringe Notes: Disposable Insulin Syringe 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Syringes; With or without Needles Notes: Syringes; With or without Needles 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Hard pack syringe Notes: Hard pack syringe >>declaring K141359<<< 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Disposable Insulin Syringe Notes: Disposable Insulin Syringe 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Hard pack syringe Notes: Hard pack syringe >>declaring K141359<<< 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Disposable Insulin Pen Needle Notes: Disposable Insulin Pen Needle 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Safety Insulin Pen Needle Notes: Safety Insulin Pen Needle 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle Notes: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Syringes; With or without Needles Notes: Syringes; With or without Needles 80 F - - PA Set, Administration, Intravascular Date Published: 05/08/2026 Desc: Safety Push Button Blood Collection Set Notes: Safety Push Button Blood Collection Set 80 F - - PA Set, Administration, Intravascular Date Published: 05/08/2026 Desc: Safelock Disposable Blood Collection Set; Disposable Blood Collection Set Notes: Safelock Disposable Blood Collection Set; Disposable Blood Collection Set 80 F - - PA Set, Administration, Intravascular Date Published: 05/08/2026 Desc: Disposable Infusion Needle; Safelock Disposable Infusion Needle Notes: Disposable Infusion Needle; Safelock Disposable Infusion Needle 80 L - - HI Set, I.V. Fluid Transer Date Published: 05/08/2026 Desc: Vented Vial Transfer Pin Notes: Vented Vial Transfer Pin 80 M - - EG Syringe, Antistick Date Published: 05/08/2026 Desc: Safelock Disposable Insulin Syringe Notes: Safelock Disposable Insulin Syringe 80 M - - EG Syringe, Antistick Date Published: 05/08/2026 Desc: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle Notes: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle 80 N - - GT Device, Flush, Vascular Access Date Published: 05/08/2026 Desc: Pre filled Syringe with Saline Notes: Pre filled Syringe with Saline

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).