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ONE-CARE PLUS Safety Lancets
MediVena, LLC · Model 1005 ONE-CARE PLUS Safety Lancets 21G x 2.4mm, ExtraFlow, Green, 100/bx, 20bx/cs · UDI-DI 00810008210215
1
510(k) clearances
14,104
Adverse events (2 deaths)
17
Recalls
158
Facilities
Description
Contact-activated ONE-CARE PLUS Safety Lancets 21G x 2.4 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety activation mechanism guarantees consistent performance, while the wide cap allows for easy twist-off, facilitating straightforward preparation for use. This innovative design provides an optimal combination of safety, comfort, and convenience.
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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Get your free API keyRead the docsData 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.