FDA Medical Device Recalls (openFDA)
QURA S.R.L.: Spectrum Medical Quantum Standard heat exchanger
- Recall number
- Z-2277-2021
- Recalling firm
- QURA S.R.L.
- Product
- Spectrum Medical Quantum Standard heat exchanger
- Status
- Terminated
- Initiated
- 2021-03-22
- Posted
- 2021-08-12
- Terminated
- 2024-04-22
- Reason
- Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
- Root cause
- Material/Component Contamination
- Action
- The firm notified their consignee of the problem by email beginning on 02/18/2021. They issued a recall noticed on 03/22/2021 by email.
- Quantity
- 1088 units
- Distribution
- US Nationwide distribution in the state of South Carolina.
- Lot, serial or model codes
- Batch Numbers: B000129, C000415, C000416, C000417
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KFM
- Firm FEI
- 3016746283
- Firm city
- Mirandola
- Firm state
- not on file
- Firm country
- Italy
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