FDA-Device2025-10-29Class III
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System 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.
Home Health US, Incorporated
Hazard
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Sold states
U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A
Affected count
4,661 lancets
Manufactured in
7672 15th St E, Sarasota, FL, United States
Products
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0226-2026Don't want to check this manually?
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