FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
- Recall number
- Z-1892-2021
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
- Status
- Terminated
- Initiated
- 2021-04-29
- Posted
- not on file
- Terminated
- 2023-03-20
- Reason
- Specific lots may have been manufactured with insufficient or incomplete welds.
- Root cause
- Nonconforming Material/Component
- Action
- Medtronic notified customers by letters dated April 202, via 2-day UPS delivery to consignees explaining the reason for recall and requesting they immediately identify and quarantine all unused product in their inventory. The product was to be returned. A Customer Confirmation Certificate was enclosed for completion via scan and email. If product was further distributed or transferred, the consignee was requested to notify those downstream customers or facilities of the recall. For questions regarding this notification, customers were instructed to contact Smiths Medical via email at fieldactions@smiths-medical.com.
- Quantity
- 2 tubing packs
- Distribution
- US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
- Lot, serial or model codes
- GTIN 00763000458133, Lot number 221249911, Use By 2022-10-22
- 510(k) numbers
- ["K171979"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- 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