NA
Hangzhou AGS MedTech Co., Ltd. · Model AG-5311-2416-2404 · UDI-DI 06959664932421
FBK
Prescription
1
510(k) clearances
591
Adverse events
43
Recalls
98
Facilities
Description
the Catheter OD is 2.4mm, working length is 1600mm, model of needle is 24, needle extension length is 4 mm, the headend type is tip forming.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Cook Incorporated | The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential ev |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.