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Disposable Sclerotherapy Needle

Telemed Systems · Model 2002 · UDI-DI 00813353010196

FBK
1
510(k) clearances
591
Adverse events
43
Recalls
98
Facilities

Description

Sure-Stop Sclerotherapy Needle 23GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length x 200cm Working Length

Recalls

DateFirmReason
2026-09-16Cook IncorporatedThe 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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
2024-10-04Hobbs 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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Data 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.