Class 2 Device Recall Presource Custom Sterile Surgical and Procedure Kits

• Date Initiated by Firm: September 30, 2011
• Date Posted: November 07, 2011
• Recall Status: Terminated on August 01, 2016
• Recall Number: Z-0170-2012
• Recall Event ID: 60069
• Product Classification: Tray, surgical - Product Code LRP
• Product: Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: ; a) Adhesive Remover Wipes, component 050-0415; ; b) Perineze Perineal Witch Hazel Pad, component 505040A; c) 24" Infant Tape Measure, component 30942P; ; d) Triple Dye Drug, 10 unit dose, component PM1022; ; ; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.
• Code Information: all recent lots of the following kit catalog numbers 03-2503F 03-2503H, 03B5615C, 4628, BA3CG4740K, BAB239109A, BAB920079C, MA1567670P, MA2CG6972D, MAN21ATAMC, MAT453740O and MATW11527D
• Recalling Firm/ Manufacturer: Cardinal Health; 1430 Waukegan Rd; Mc Gaw Park IL 60085-6726
• For Additional Information Contact: Michele B. Donatich R.N.; 847-473-1500
• Manufacturer Reason for Recall: Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturers do not have all necessary FDA registrations or filings needed for these components.
• FDA Determined Cause: Component design/selection
• Action: Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 30, 2011 to the affected wholesale consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels to affix to the front side of each affected Presource kit and shipping carton in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit, the consignees were instructed to contact Distributor Management Group at 800-635-6021. This wholesale recall was expanded to include additional kits via letter dated October 5, 2011, with the same instructions as listed above. For questions regarding this recall call 800-292-9332.
• Distribution: Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin
• 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.