The Recall Desk
HighFDA (Devices)·Z-1929-2021·Announced 2021-06-30

Freestyle Lancets 28G Recalled Due to Temperature Damage During Shipping

Cardinal Health is recalling Freestyle Lancets due to temperature exposure during shipping that may cause inaccurate results. Affected devices were distributed in Florida, Georgia, and South Carolina.

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: FDA Class II medical device with potential for inaccuracy in diabetes management. No hospitalizations or illnesses reported. Classified as a risk-of-harm product where injury has not yet been reported, per severity rubric criteria.

Plain-English summary

Cardinal Health Inc. is recalling Freestyle Lancets 28G (Item Number 2975670), with 377 boxes of 100 lancets affected. Distribution was nationwide, with documented cases in Florida, Georgia, and South Carolina.

During shipment, these lancets were exposed to temperatures of 31.9°F, intermittently occurring over approximately two hours and fifteen minutes. This temperature exposure may cause the devices to produce inaccurate results.

Inaccurate lancet performance could compromise diabetes management by producing incorrect blood glucose readings. Consumers should discontinue use of affected devices and contact their healthcare provider or Cardinal Health for replacement or further guidance. All lot numbers shipped between February 23, 2021 and March 10, 2021 are affected.

The recalled product

Product
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Blood Glucose Monitoring
Hazard
  • inaccurate-results
  • temperature-damage

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: 699073130013 All lots numbers shipped from 2/23/201 to 3/10/2021

Distribution

Distributed nationwide across the United States.

Related recalls

Same category