FDA-Device2024-07-10Class II
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Code Cart Drawer 2 Adlt Peds, Pack #ACC010366A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. d. Medline Drawer 2, Pack #ACC010375A, containing a
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
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Code Cart Drawer 2 Adlt Peds, Pack #ACC010366A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. d. Medline Drawer 2, Pack #ACC010375A, containing a Pure Pouch component Reorder #TRI67630, Sterile Straight Mayo Scissors, 5.5" and Sterile Magill Forceps, Reorder #66790. e. Medline Adult Drawer 4, Pack #ACC010389C, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. f. Medline Code Cart Drawer 1 Adult Airwa, Pack #ACC010451A, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. g. Medline Emergency Airway Drawer, Pack #ACC010492, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. h. Medline Drawer 2, Pack #ACC010681, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile and Sterile Magill Forceps, Reorder #66790. i. Medline Drawer 2, Pack #ACC010690, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. j. Medline Drawer Two #IMF 109694, Pack #ACCVB1000A, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. k. Medline First Hlth Moore Bronchoscopy, Pack #DYK1015098B4, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. l. Medline Trunk Kit 1EA, Pack #DYKM2013A, containing a Pure Pouch component #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Difficult Kit, Pack #DYKM2135, containing a Pure Pouch component Sterile Curved Kelly Hemostat, Reorder #66175 and Sterile Magill Forceps, Reorder #66790. n. Medline Wound Care Kit, Pack #DYNDW1033B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2232-2024Don't want to check this manually?
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