Sterile blood lancets recalled over incorrect or missing device identifier codes
Home Health US is recalling 4,661 One Step Sterile Lancets because of incorrect or missing Unique Device Identifier codes.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 as a documentation problem: the record cites incorrect or missing device identifier codes with no product defect and an FDA Class III designation.
Plain-English summary
One Step Sterile Lancets for Single Use, in 30g, 28g and 23g sizes, are being recalled. The lancing system is intended for the hygienic collection of capillary blood for testing from the side of a fingertip.
The recall is due to incorrect or absent Unique Device Identifier (UDI) codes.
The recall covers 4,661 lancets, including UDI-DI 06949517008861 (30g, lot 2312290802) and 06949517008854 (28g, lot 2406310201). The product was distributed nationwide through Amazon, including to Arizona, California, Florida, Illinois, North Carolina, New Mexico, New York, Tennessee, Texas and Virginia. The FDA has classified the recall as Class III.
The enforcement record describes an identifier coding problem rather than any defect in the lancets themselves, and reports no injuries.
The recalled product
- 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…
- Manufacturer
- Home Health US, Incorporated
- Category
- Medical Device — Lancet
- Affected units
- 4,661
Distribution
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