Class 2 Device Recall Cardinal Health" Clear Leggings

• Date Initiated by Firm: February 25, 2021
• Create Date: March 24, 2021
• Recall Status: Terminated on January 09, 2024
• Recall Number: Z-1301-2021
• Recall Event ID: 87431
• Product Classification: Stocking, elastic - Product Code ILG
• Product: In-View Clear Leggings Sterile Non-Sterile
• Code Information: Catalog Number 8430N; Lot number's: 3290DR1 and 3300DR1
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• Manufacturer Reason for Recall: Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
• FDA Determined Cause: Nonconforming Material/Component
• Action: A Recall notification letter titled, "URGENT MEDICAL DEVICE RECALL" was sent to consignees on 02/25/2021 via FedEx priority overnight. The consignee is requested to follow the following instructions: 1. CHECK all storage and usage locations to confirm whether they have any units of the affected product codes and lot numbers listed in Attachment 1. 2. SEGREGATE and QUARANTINE all impacted on-hand product. 3) RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product they have quarantined. They are requested to please respond regardless of whether or not they have affected product. 4. NOTIFY any customers to whom they may have distributed, or forwarded product affected by this recall. The consignee's notification to their customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product. 6. CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it.
• Quantity in Commerce: 1020 units
• Distribution: Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and Canada.
• 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.