FDA Medical Device Recalls (openFDA)
Medtronic Minimally Invasive Therapies Group: MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
- Recall number
- Z-1007-2018
- Recalling firm
- Medtronic Minimally Invasive Therapies Group
- Product
- MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
- Status
- Terminated
- Initiated
- 2017-10-14
- Posted
- not on file
- Terminated
- 2018-06-15
- Reason
- Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.
- Root cause
- Process control
- Action
- Medtronic began notifying customers via telephone on October 14, 2017, and all consignees were notified via Federal Express or certified mail on October 17, 2017. The letter informs customers that they were shipped devices that were not sterile. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.
- Quantity
- not on file
- Distribution
- U.S.
- Lot, serial or model codes
- UDI: 10884521126473/20884521126470 Lot: 1717900160.
- 510(k) numbers
- ["K120674"]
- PMA numbers
- not on file
- Product code
- MPB
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28