Class 2 Device Recall Sterile Disposable Drape

• Date Initiated by Firm: October 01, 2019
• Create Date: July 22, 2022
• Recall Status: Terminated on June 06, 2024
• Recall Number: Z-1449-2022
• Recall Event ID: 90475
• Product Classification: Drape, surgical, exempt - Product Code PUI
• Product: Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
• Code Information: UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Customer Service; 800-8289000
• Manufacturer Reason for Recall: Packaging seal integrity not validated resulting in a lack of sterility assurance.
• FDA Determined Cause: Package design/selection
• Action: Recall notice issued October 1, 2019 via letter mailed USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or email: emailorders@aesculapusa.com
• Quantity in Commerce: 4500 pieces
• Distribution: United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and 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.