OneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping
Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.
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: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The lancets are medical devices used for blood glucose testing, and temperature exposure that may cause inaccurate results poses a risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported score as 3.
Plain-English summary
Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G (Item Number 5541628, NDC 812608030019) because the devices were exposed to freezing temperatures of 31.9°F during shipment. The exposure occurred intermittently over a 2 hour and 15 minute period. This temperature exposure may cause inaccurate test results.
The recall affects 4,896 boxes of lancets containing all lot numbers shipped from February 23, 2021 to March 10, 2021. The affected devices were distributed to Florida, Georgia, and South Carolina.
The FDA has classified this as a Class II recall. Consumers with questions about this recall should contact Cardinal Health Inc. or their healthcare provider.
The recalled product
- Product
- ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
- 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: 812608030019 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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