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Home Health US, Incorporated: One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is

Medical DevicesSource: FDA (device) · Date: 2025-10-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Home Health US, Incorporated
Product
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.
Reason / hazard
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Classification
Class III
Status
Ongoing
Distribution / sold at
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
Recall initiated
2025-07-25
Code info
UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Product quantity
4,661 lancets
Voluntary mandated
Voluntary: Firm initiated
City
Sarasota
State
FL
Country
United States
Event id
97350
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