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Clear-Jet Injection Catheter
FINEMEDIX CO.,LTD. · Model FM-EI0002(I2)(2300)(0.08T) · UDI-DI 08809327352425
FBK
Prescription
1
510(k) clearances
570
Adverse events
42
Recalls
98
Facilities
Description
23G-4mm/ 0.08T/ 2,300mm/ Non-head
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
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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.