FDA-Device2012-09-05Class II
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
SRI Surgical
Hazard
Distribution of a product that did not meet specifications. (labeling error)
Sold states
Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.
Affected count
802,135
Manufactured in
12425 Race Track Rd, N/A, Tampa, FL, United States
Products
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2300-2012Don't want to check this manually?
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