Z-1937-2021 Class II Ongoing
FDA device recall Z-1937-2021 was initiated by Cardinal Health Inc. on March 16, 2021 and is designated Class II. Reason for recall: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. The recall status is ongoing. Affected quantity: 531 boxes of 100 lancets.
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- March 16, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 531 boxes of 100 lancets
Product Description
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Reason for Recall
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Distribution Pattern
US Nationwide distribution in the states of FL, GA, SC.
Code Information
NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021