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SafetiCet
NSP TECH PTE LTD · Model SC-150 · UDI-DI 18887629000029
10
510(k) clearances
14,134
Adverse events (2 deaths)
17
Recalls
164
Facilities
Description
A sterile and single use device, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider or a patient (e.g., a diabetic), typically at the fingertip. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site
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.