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Advocate Lancets Safety 21 Gauge 2.4mm

DIABETIC SUPPLY OF SUNCOAST, INC. · Model 634 · UDI-DI 00894046001899

FMK
10
510(k) clearances
14,110
Adverse events (2 deaths)
17
Recalls
160
Facilities

Description

Advocate Lancets Safety 21 G 2.4 mm, sterile, for capillary blood sample, needle automatically retracts, ready to use, no loading needed, single use only.

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.