Class 2 Device Recall Presource Custom Sterile Surgical and Procedure Kits

• Date Initiated by Firm: December 23, 2011
• Date Posted: January 27, 2012
• Recall Status: Terminated on August 01, 2016
• Recall Number: Z-0925-2012
• Recall Event ID: 60845
• Product Classification: General surgery tray (kit) - Product Code LRO
• Product: Presource Custom Sterile Surgical and Procedure Kits; general surgery 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: a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; The restraint is used to secure an infant during a circumcision procedure. Product Usage: 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. The restraint is used to secure an infant during a circumcision procedure.
• Code Information: all recent lots of the following kit catalog numbers SBA48UMCHF, SMA21CIDCB, SMA21CRDCC, SMA21CRDCD, SRHHFCIMM1, SRHHFCIMM2, SRHHFCIMMA and SRHHFCIMMB
• 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: The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance.
• FDA Determined Cause: No Marketing Application
• Action: Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 23, 2011 to the affected hospital consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected component upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers 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/replacement the consignees were instructed to contact the folowing: Hospitals - Presource Sales Operations at 800-766-0706; Federal Government facilities - Government Customer Service at 800-444-1166; and Distributors - Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.
• Quantity in Commerce: 15,369 kits in total
• Distribution: Nationwide Distribution (USA) including the states of: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Virginia, Washington and West Virginia.
• 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.