Class 2 Device Recall Presource PBDS, Kit, Common

• Date Initiated by Firm: February 20, 2018
• Create Date: July 18, 2018
• Recall Status: Terminated on November 04, 2019
• Recall Number: Z-2481-2018
• Recall Event ID: 80289
• Product Classification: Tray, surgical - Product Code LRP
• Product: Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.
• Code Information: Product Code SPK692448A (Lot Numbers 820352, 821938, 822522, 825665, 826987, 839110), Product Code SP1692448B (Lot Number 841315, 841803).
• FEI Number: 3001236905
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• For Additional Information Contact: 800-292-9332
• Manufacturer Reason for Recall: A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
• FDA Determined Cause: Packaging
• Action: Cardinal Health notified customers via Fed Ex overnight, on about 02/21/2018. The URGENT PRODUCT RECALL letter instructed customers to: 1) Inspect your inventory for the affected product code and lot number; 2)Segregate and quarantine all product on hand; 3) Return enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined; 4) Notify any customers to whom you may have distributed product affected by this recall; 5)Contact Customer Service at 800-964-5227 to arrange return and credit. Customers were also instructed to return any affected kit on site.
• Quantity in Commerce: 8,928 kits total
• Distribution: US Nationwide Distribution in the states of California.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.