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U.S. Department of Health and Human Services

Class 2 Device Recall Automark, Mark, Markslim, Repomark

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  Class 2 Device Recall Automark, Mark, Markslim, Repomark see related information
Date Initiated by Firm August 05, 2021
Create Date September 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-2491-2021
Recall Event ID 88430
Product Classification Guide, needle, surgical - Product Code GDF
Product Mammary Nodules Localization
Code Information Model Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D
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 320 units
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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