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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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.
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
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.
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