Medtronic InterStim Ground Pad REF 041826
FDA device recall Z-2365-2023 · posted 2023-08-10 · Open, Classified
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EZW
- Quantity affected
- 360 packs (36 kits of 10 packs each)
- Distribution
- International distribution to the country of Iran.
- Date initiated
- 2023-07-06
- Date posted
- 2023-08-10
- Location
- Minneapolis, MN
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