Purpose: To determine the supply chain of TPN to Grocery Store Chain A and product lots potentially associated with illnesses.
Methods: Case clusters identified by CDC were included in the traceback investigation based on the following criteria: geographic distribution, case exposure dates, and laboratory findings. FDA and state partners collected shipment records at the points of service, distribution centers, and importer. The records were reviewed and analyzed to determine product identifying information along the supply chain. Federal and state partners tested regulatory and retail samples of TPN collected along the supply chain.
Results: Grocery Store Chain A received bulk TPN solely from Distribution Center B. Distribution Center B received product from a single Importer C, which is supplied by two foreign suppliers (D and E) located in Turkey. Two intact samples of TPN collected along the supply chain, one open retail sample, and multiple open samples from consumer homes tested positive for the same strain of Salmonella Enteritidis found in clinical cases. Records collected provided the following information for traceback identification of TPN lots associated with illness: 1) purchase dates, 2) shipment frequency to points of service, and 3) availability of lots stored in distribution center and importer warehouses. The overall investigation of TPN led to the implication of 3 lots by traceback investigation and 1 lot by positive laboratory results.
Significance: The traceback investigation performed by FDA and state partners along with laboratory sampling led to the voluntary recall of 21,000 lbs. of TPNs by Importer C. FDA placed Foreign Suppliers D and E on import alert.