Home › MediVena, LLC › ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm

ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm

MediVena, LLC · Model ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm · UDI-DI 00810008210673

FMK

510(k) clearances

14,134

Adverse events (2 deaths)

Recalls

164

Facilities

Description

MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. The product has T-shape main housing and concaved button for stable grip within the hand and easy activation. ONE-CARE PRO Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap by a full turn of 360 degree, then pull it out, STEP 2 Press the top push button to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container.

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.