MEDLINE INDUSTRIES, LP - Northfield recalls Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch wi

Recalled July 10, 2024 · FDA recall Z-2230-2024 · 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. · FDA Class II

Units

7,673 total non-sterile kits

Sold at

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.

Description

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.

Product

Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. c. Medline Intubation Tray (Adult), Pack #DYNJAA245A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. d. Medline Adult Main Disp. Intub Part A, Pack #DYNJAA262A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. e. Medline Adult Anesthesia Tray, Pack #DYNJAA276, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. f. Medline Baby Care Kit, Pack #DYKL1025 and Pack #DYKL1025H, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.

Manufacturer(s)

MEDLINE INDUSTRIES, LP - Northfield

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →