FDAFDA · Food and drugs·Recall number Z-0164-2023
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Published November 9, 2022 · Recall initiated: September 30, 2022
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
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
- Lot
- GTIN (01) 40193489385404, Lot Number 22DBE139
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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