ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
FDA Recall Z-1938-2021 · Posted None
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Recalling FirmCardinal Health Inc.
Recall StatusOpen, Classified
Product CodeNBW
Date Initiated2021-03-16
Product Quantity144 boxes of 25 strips
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.
Firm 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)
Root Cause
Environmental control
Distribution Pattern
US Nationwide distribution in the states of FL, GA, SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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