Home › PRESTIGE AMERITECH, LTD. › PremierPro Lancet
PremierPro Lancet
PRESTIGE AMERITECH, LTD. · Model 7552 · UDI-DI 00811220030360
10
510(k) clearances
14,134
Adverse events (2 deaths)
17
Recalls
161
Facilities
Description
Lancet, Pressure, BLUE Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.