Class II
Medical Device Recall: Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
MEDLINE INDUSTRIES, LP - Northfield · March 14, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
12,588 total sterile kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2226-2024
Status: ongoing
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