Device product
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Z-0164-2023
Product summary
- Event
- Event 90946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-0164-2023
Official wording
Reason: Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information: GTIN (01) 40193489385404, Lot Number 22DBE139
Distribution pattern: US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Derived failure modes
-
Unknown
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.