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U.S. Department of Health and Human Services

Class 2 Device Recall Cytocut

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  Class 2 Device Recall Cytocut see related information
Date Initiated by Firm August 05, 2021
Create Date September 20, 2021
Recall Status1 Open3, 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 2		 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.
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