FDA-Device2022-11-09Class II

MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.

MEDLINE INDUSTRIES, LP - Northfield
Hazard

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Sold states
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Affected count
60 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0164-2023

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