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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

1,297
Registered devices
14,104
Adverse events
17
Recalls
110
510(k) clearances

Devices with this code

STERiLANCE SteriHeel Plus Heel Incision Safety Lancet — Sterilance Medical (Suzhou) Inc.ergoLance, safety lancet — HTL STREFA S ADropSafe Medlance Plus, safety lancets — HTL STREFA S AVerifine — Promisemed Medical Devices Inc.xinle — Hebei Xinle Sci&Tech Co., Ltd.SurgiLance Safety Lancet — MEDIPURPOSE PTE. LTD.Medline — MEDLINE INDUSTRIES, INC.Twist Lancet (26G) — Shandong Lianfa Medical Plastic Products CO.,LTDSafety Lancet (28G) — Shandong Lianfa Medical Plastic Products CO.,LTDMiniCollect — Greiner Bio-One GmbHPIP — AMITY HOLDINGS, LLCSTERiLANCE Press2 Disposable Safety Lancet — Sterilance Medical (Suzhou) Inc.VivaGuard — Able Diagnostics IncSafety Lancet (18GBlade) — Shandong Lianfa Medical Plastic Products CO.,LTDMedline — MEDLINE INDUSTRIES, INC.ONE-CARE Safety Lancets — MediVena, LLCTwist Lancet (32G) — Shandong Lianfa Medical Plastic Products CO.,LTDLancing Device — Shandong Lianfa Medical Plastic Products CO.,LTDSafety Lancet (21G) — Shandong Lianfa Medical Plastic Products CO.,LTDSterilance Press Pressure Activated Safety Lancet — SteriLance Medical (Suzhou) Inc.Tenderlett Finger Incision Device — ACCRIVA DIAGNOSTICS HOLDINGS, INC.In Touch Refill Kit — LIVONGO HEALTH, INCUnistik 3 — OWEN MUMFORD LIMITEDSafety Lancet (21G) — Shandong Lianfa Medical Plastic Products CO.,LTD

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.