Class 2 Device Recall Cytocut

• Date Initiated by Firm: August 05, 2021
• Create Date: September 20, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2490-2021
• Recall Event ID: 88430
• Product Classification: Needle, aspiration and injection, disposable - Product Code GAA
• Product: Aspirated Cyto-Histological Biopsy needle
• Code Information: Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A
• Recalling Firm/ Manufacturer: M.D.L. S.r.l.; Via Tavani N. 1/A; Delebio Italy
• For Additional Information Contact: Simone DellOca; 390 342 682130
• Manufacturer Reason for Recall: Sterility assurance may be compromised.
• FDA Determined Cause: Other
• Action: The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers.
• Quantity in Commerce: 2750 devices
• Distribution: Nationwide
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.