Cardinal Health Inc. ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Brand
Cardinal Health Inc.
Lot Codes / Batch Numbers
NDC/UPC: 812608030019 All lots numbers shipped from 2/23/201 to 3/10/2021
Products Sold
NDC/UPC: 812608030019 All lots numbers shipped from 2/23/201 to 3/10/2021
Cardinal Health Inc. is recalling ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 due to Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which ma. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Recommended Action
Per FDA guidance
On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements. Actions Required 1. INSPECT your inventory for the affected product. 2. SEGREGATE and QUARANTINE all affected product. 3. RETURN the enclosed acknowledgment form via fax to 1-817-868-5362 or email to rxrecalls@inmar.com, even if you do not have any product on hand. 4. CONTACT Inmar to arrange for return and credit of any affected product: 1-855-696-2074 (9:00 AM to 5:00 PM, Monday thru Friday)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026