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Haemolance Plus, safety lancet

HTL STREFA S A · Model Max Flow, 1.5mm 1.6mm · UDI-DI 05907506237396

FMK
10
510(k) clearances
14,104
Adverse events (2 deaths)
17
Recalls
158
Facilities

Description

Safety lancets are sterile, single use medical devices intended for capillary blood sampling.

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 inaccurate results.
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 inaccurate results.
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 inaccurate results.
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 inaccurate results.
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 into the cap. This a
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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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.