Class 2 Device Recall AVID Medical, Inc.

• Date Initiated by Firm: February 18, 2020
• Create Date: March 19, 2020
• Recall Status: Terminated on November 23, 2020
• Recall Number: Z-1516-2020
• Recall Event ID: 85049
• Product Classification: Cardiac catheterization kit - Product Code OES
• Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
• Code Information: Item Codes:ADVC033-16, ADVG034-15, ADVU018-24, JNTH001-04, JNTH001-05, JNTH002-05, SHER019-07, YAVA100-05. Lot Numbers: 1344066, 1344358, 1353858, 1353860, 1354012, 1359439, 1361116, 1361767, 1363232, 1365746, 1379393. Expiration dates: 2/28/21 thru 7/30/2022.
• Recalling Firm/ Manufacturer: Avid Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Nichole Early; 828-338-7568
• Manufacturer Reason for Recall: The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
• FDA Determined Cause: Other
• Action: URGENT MEDICAL DEVICE RECALL NOTICE letters, dated February 18, 2020, were distributed to customers. Letter provides identification of the issue, health risk and action to take. Customers were instructed to take the following required actions: " Review all storage and usage locations and segregate and quarantine any trays with an item code and lot number listed on attached Exhibit A. " Complete and return the enclosed Recall Response Form to Sharon.moll@owens-minor .com. Please respond even if you do not have any trays subject to this recall. " Upon receipt of your completed Recall Response Form, product return instructions will be provided and a RGA will be issued, if you do have trays subject to this recall. " If you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Recall Notice . Your assistance is appreciated and necessary to prevent any unintended use of the product. If you have any questions, call Sharon Moll at 757-566-9844.
• Quantity in Commerce: 1,906 each
• Distribution: US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
• 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.