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MEDLINE INDUSTRIES, LP - Northfield recalls Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Shar
Recalled July 10, 2024 · FDA recall Z-2227-2024 · 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
12,588 total 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
Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →