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STAT Medical Devices
Stat Medical Devices, Inc. · Model Comfort Thins Twist-Off Lancet · UDI-DI 00709334581215
10
510(k) clearances
250
Adverse events
1
Recalls
87
Facilities
Description
The sterile, single-use lancets is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-25 | Home Health US, Incorporated | Due to incorrect/lack of Unique Device Identifier (UDI) codes. |
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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.