FDA-Device2024-07-10Class II
Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Sold states
US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.
Affected count
7,673 total non-sterile kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2229-2024Don't want to check this manually?
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