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.
FDA Recall Z-2300-2012 · Posted 2012-08-29
Recalling FirmSRI Surgical
Recall StatusTerminated
Product CodeFTN
Date Initiated2008-07-16
Date Terminated2012-09-10
Product Quantity802,135
Reason for Recall
Distribution of a product that did not meet specifications. (labeling error)
Firm Action
SRI sent a "MEDICAL DEVICE CORRECTION" letter dated July 16, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 813-891-9550 ext. 3124 for questions regarding this recall.
Root Cause
Component change control
Distribution Pattern
Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.