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U.S. Department of Health and Human Services

Class 2 Device Recall InterStim SelfAdhesive Ground Pad

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  Class 2 Device Recall InterStim SelfAdhesive Ground Pad see related information
Date Initiated by Firm July 06, 2023
Date Posted August 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-2365-2023
Recall Event ID 92701
PMA Number P070004S001 P080025 
Product Classification Stimulator, electrical, implantable, for incontinence - Product Code EZW
Product Medtronic InterStim Ground Pad REF 041826
Code Information Product Number: 041826; UDI: 20763000343273; Lot Number: 60347246
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Customer Service
1800-962-9888
Manufacturer Reason
for Recall		 Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
FDA Determined
Cause 2		 Under Investigation by firm
Action The consignee recall notification was sent out via mail on 07/06/2023. The letter instructs the consignee to return any affected product they may have, and to forward the notification to those who need to be aware within the organization or to any location which the devices have been transferred. Consignee also asked to complete and return a confirmation.
Quantity in Commerce 360 packs (36 kits of 10 packs each)
Distribution International distribution to the country of Iran.
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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