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Verifine

Promisemed Medical Devices Inc. · Model SL-23-18M · UDI-DI 00850011833339

FMK

510(k) clearances

14,110

Adverse events (2 deaths)

Recalls

160

Facilities

Description

Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.

Recalls

Date	Firm	Reason
2021-03-16	Cardinal 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.
2021-03-16	Cardinal 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.
2021-03-16	Cardinal 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.
2021-03-16	Cardinal 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.
2013-08-19	Roche 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
2013-07-10	Becton Dickinson & Company	The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
2013-07-03	KooJoo Trading Company	Lancets were not sterilized within the dose range established by sterilization validation.
2009-05-13	Roche Diagnostics Corp.	The lancet cap may be missing, which could result in an unintended lancet stick to the user.
2008-08-27	Sarstedt Inc	The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated.
2008-07-18	Facet Technologies	The 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.