Class 2 Device Recall Hang&Go (kit for hyperthermic perfusion),

• Date Initiated by Firm: April 30, 2021
• Create Date: July 09, 2021
• Recall Status: Terminated on February 05, 2024
• Recall Number: Z-2048-2021
• Recall Event ID: 87926
• 510(K)Number: K161613
• Product Classification: Warmer, thermal, infusion fluid - Product Code LGZ
• Product: Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
• Code Information: Lot Numbers: F180266 F180315 F190169
• Recalling Firm/ Manufacturer: RanD S.r.l.; Strada Statale 62; Medolla Italy
• Manufacturer Reason for Recall: The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
• FDA Determined Cause: Material/Component Contamination
• Action: An Urgent Medical Device Recall notification letter dated 4/30/21 was sent to customers. Reason for the Voluntary Recall: Our sterilization contractor informed us about a quality issue possibly affecting the sterilization process of a certain number of RAND products, thus leading us to open an immediate investigation. We have determined that the lots mentioned in the table below may be non-sterile. Risk to Health: The exposure to non-sterile products may result in an increased risk of patient infection. However we have not received any adverse event report regarding patient infection events associated with this field safety notice, so far. No specific follow up activities are required if the products have already been used. Actions to be taken by the Customer/User: Please proceed as follows: 1. Please check if you still have in your stock products belonging to the lot numbers below. Please refer to the reference code (REF) and the lot number (LOT) on the product label. 2. If you identify affected product, cease use immediately and put these products in quarantine. Please be sure that they are properly and clearly identified as on-hold to prevent their unintentional use. 3. Please fill in the form on the last page and return it to cristina.vaccari@rand-biotech.com as soon as possible, but no later than May 30, 2021. The form must be completed and returned even if you do not have affected product on hand. 4. If you identified non-conforming products in your inventory, you will receive further instructions on product disposition (return them to RAND or destroy them). Type of Action by the Company: No alternative products can be used, because only RanD sterile medical devices can be used in combination with the Performer HT equipment. RanD S.p.A. has already validated a different sterilization provider. New sterile products will be available in 1 - 2 month time. Contact details: If you have any questions or concerns regarding this notification, d
• Quantity in Commerce: 72
• Distribution: The products were distributed to the following US states: FL, IL, TN, WI
• 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.

• 510(K) Database: 510(K)s with Product Code = LGZ