Class 2 Device Recall Cohesive bandages, CBN1106

• Date Initiated by Firm: November 17, 2015
• Date Posted: January 30, 2016
• Recall Status: Terminated on September 13, 2016
• Recall Number: Z-0735-2016
• Recall Event ID: 72910
• Product Classification: Tape and bandage, adhesive - Product Code KGX
• Product: MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
• Code Information: Item No. Lot No. Expiration Date, CBN1106 12113H10A Oct-15, CBN1106 13033H10A Feb-16, CBN1106 13053H10A Apr-16, CBN1106 13083H10A Jul-16, CBN1106 13103H10A Sep-16, CBN1106 13113H10A Oct-16, CBN1106 14013H10A Dec-16, CBN1106 14043H10A Mar-17, CBN1106 14053H10A Apr-17, CBN1106 14063H10A May-17, CBN1106 14083H10A Jul-17, CBN1106 14093H10A Aug-17, CBN1106 14093H10A Aug-17, CBN1106 14113H10A Oct-17, CBN1106 14123H10A Nov-17, CBN1106 15013H10A Dec-17, CBN1106 15023H10A Jan-18, CBN1106 15033H10A Feb-18, CBN1106 15043H10A Mar-18, CBN1106 15053H10A Apr-18, CBN1106 15063H10A May-18, CBN1106 15083H10A Jul-18, CBN1106 15073H10A Jun-18.
• FEI Number: 3003753847
• Recalling Firm/ Manufacturer: Owens & Minor Distribution, Inc.; 9120 Lockwood Blvd; Mechanicsville VA 23116-2015
• For Additional Information Contact: 804-723-7000
• Manufacturer Reason for Recall: MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
• FDA Determined Cause: Under Investigation by firm
• Action: The firms recall strategy is as follows : recall was initiated by the Owens & Minor Home Office Recall Officer. The Home Office Recall Officer e-mailed the following documents to the Distribution Center (DC) Recall Officer at each affected DC: 1. DC Recall Letter (specific instructions for the DCs), 2. Recall Inventory Report form (for the DCs to record the amount of affected product quarantined), 3. Customer Letter (specific instructions for the customers), 4. Recall Return Response Form (for the customers to report back the details of the quantity of affected product in their inventory), 5. Attachment 1 (a document that provides examples of the product labeling), 6. Recall Checklist (a checklist for the DCs listing the actions that need to be completed), and 7. Recall Combine Queries spreadsheet (listing customers and current on-hand inventory at the DCs). The DC Recall Officer at each DC forwarded the information to the DC Customer Service team. The DC Customer Service team notified each impacted customer via e-mail or letter based upon the customers recorded preference. Level to which the recall was initiated: The recall was initiated to the level of the customer (i.e., hospitals, clinics, surgery centers). Follow-up plans: A minimum of three (3) attempts are made to obtain an acknowledgment from the customer that they received the recall notification. An attempt to determine the status of non-responsive businesses will be made. If the non-responsive business is still viable, an attempt will be made to determine the employee responsible for management of recalls and the recall notice will be sent to that employee. If the business is no longer viable, the steps described below for out-of-business accounts will be followed. Sub-recall: No sub-recall is required. These products are supplied to User Facilities and not distributed to commercial sub-accounts. Plans for effective checks: 1. Check records to ensure that the initial recall not
• Quantity in Commerce: 64011
• 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.