Class 2 Device Recall JacksonPratt Hemaduct Silicone Round Drain, 10FR W/Trocar.

• Date Initiated by Firm: April 21, 2017
• Create Date: May 23, 2017
• Recall Status: Terminated on December 27, 2017
• Recall Number: Z-2138-2017
• Recall Event ID: 77127
• Product Classification: Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
• Product: Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
• Code Information: Catalog Number: SU130-0321 Lot Numbers: 1161202 1161203 1161364 1161365 1161471 1161472 1161601 1161602 1170030 1170031
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 1500 S Waukegan Rd; Waukegan IL 60085-6728
• For Additional Information Contact: Customer Advocacy; 800-292-9332
• Manufacturer Reason for Recall: Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
• FDA Determined Cause: Process design
• Action: CardinalHealth sent an Urgent Product Recall letter dated April 21, 2017, to all affected customers (including response firm). Customers were instructed to inspect recalled lots and return any affected product found. Distributors were instructed to notify their customers. Affected product will be destroyed. To arrange for return of any affected product by contacting Customer Service at the following numbers: Hospital800.964.5227 Distributor800.635.6021 Federal Government800.444.1166 All Other Customers888.444.5440 Customers with questions were instructed to contact Cardinal Health Customer Advocacy at 800-292-9332. For questions regarding this recall call 847-887-4138.
• Distribution: Nationwide Distribution
• 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.