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Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FDA product code FMK · Class 2 · General, Plastic Surgery

1,322
Registered devices
14,134
Adverse events
17
Recalls
111
510(k) clearances

Devices with this code

Twist Lancet (33G) — Shandong Lianfa Medical Plastic Products CO.,LTDEasy Comfort Thin Top Lancets 30G — HOME AIDE DIAGNOSTICS, INC.STERiLANCE Elite Disposable Safety Lancet — Sterilance Medical (Suzhou) Inc.Clarity — Ningbo Medsun Medical Co., Ltd.Lancing Device — Shandong Lianfa Medical Plastic Products CO.,LTDSafety Lancet PAII (21G) — Shandong Lianfa Medical Plastic Products CO.,LTDPull-top Lancet (26G) — Shandong Lianfa Medical Plastic Products CO.,LTDMediHeel — AMITY HOLDINGS, LLCTestWell Choice 23G Safety Lancet — Boca Med, LLCNovaPlus — AMITY HOLDINGS, LLCBlueline — Transparent Supply Solutions Ltd.Sterilized Eol Lancet Plus — HLB CO.,LTDTwist Lancet (31G) — Shandong Lianfa Medical Plastic Products CO.,LTDxinle — Hebei Xinle Sci&Tech Co., Ltd.SteriLance Lancing Device LDE 4 — Sterilance Medical (Suzhou) Inc.Safety Lancet (18GBlade) — Shandong Lianfa Medical Plastic Products CO.,LTDCOMFORT TOUCH PLUS — Slv Pharmaceuticals LLCHuahong — Tianjin Huahong Technology Co., Ltd.Unistik Touch — OWEN MUMFORD LIMITEDBigfoot Lancets 33 Gauge — Bigfoot Biomedical, Inc.Pro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, INC.Safety Lancet (28G) — Shandong Lianfa Medical Plastic Products CO.,LTDMckesson — MCKESSON MEDICAL-SURGICAL INC.MPD Lancet Ultra Thin (Box of 100) — Medical Plastic Devices M.P.D. Inc

Recent recalls

DateFirmReason
2021-03-16Cardinal Health Inc.Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause in
2021-03-16Cardinal Health Inc.Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause in
2021-03-16Cardinal Health Inc.Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause in
2021-03-16Cardinal Health Inc.Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause in
2013-08-19Roche Diagnostics Operations, Inc.Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back
2013-07-10Becton Dickinson & CompanyThe Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
2013-07-03KooJoo Trading CompanyLancets were not sterilized within the dose range established by sterilization validation.
2009-05-13Roche Diagnostics Corp.The lancet cap may be missing, which could result in an unintended lancet stick to the user.
2008-08-27Sarstedt IncThe product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated.
2008-07-18Facet TechnologiesThe Alternate Site Cap was not included in the package as indicated on the labeling.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.