The Recall Desk
HighFDA (Devices)·Z-1937-2021·Announced 2021-06-30

OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping

Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a blood glucose monitoring tool with potential for inaccurate results due to temperature exposure, but no reported injuries or illnesses. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cardinal Health Inc. is recalling OneTouch Ultrasoft Lancets (100-count, Item Number 3007788) due to temperature exposure during shipment. The devices were exposed to 31.9°F intermittently over a 2 hour and 15 minute period, which may cause inaccurate test results.

The recall affects 531 boxes of lancets with all lot numbers shipped between February 23, 2021 and March 10, 2021. The affected products were distributed in Florida, Georgia, and South Carolina.

Consumers who have the affected lancets should discontinue use and contact their healthcare provider or Cardinal Health for replacement devices or alternative blood glucose testing methods.

The recalled product

Product
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Blood Glucose Monitoring
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Cardinal Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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