FDAFDA · Food and drugs·Recall number Z-1941-2021
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Published June 30, 2021 · Recall initiated: March 16, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health Inc.
- Distributor
- US Nationwide distribution in the states of FL, GA, SC.
- Lot
- NDC/UPC: 8373982700 All lots numbers shipped from 2/23/201 to 3/10/2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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