Z-1937-2021Class II

ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788

Name: Z-1937-2021 ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Creator: Cardinal Health Inc.
Published: 2021-03-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-03-16 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health Inc. began a recall of ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 on 2021-03-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1937-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-16
Posted: 2021-06-23
Recalling firm: Medtronic, Inc.
Product: ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: 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 [email protected], 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)
Quantity in commerce: 531 boxes of 100 lancets
Distribution: US Nationwide distribution in the states of FL, GA, SC.
Product codes and lots: NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1937-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1929-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1930-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1931-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1932-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1933-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1934-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1935-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1936-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1937-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1938-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1939-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1940-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1941-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1942-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23

Product code FMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)