SRI Surgical recalls Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience

Recalled September 5, 2012 · FDA recall Z-2300-2012 · SRI Surgical

Hazard

Distribution of a product that did not meet specifications. (labeling error) · FDA Class II

Units

802,135

Sold at

Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.

Description

Distribution of a product that did not meet specifications. (labeling error)

Product

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.

Manufacturer(s)

SRI Surgical

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