FDA Medical Device Recalls (openFDA)
Sanarus Medical Inc: Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
- Recall number
- Z-0935-03
- Recalling firm
- Sanarus Medical Inc
- Product
- Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
- Status
- Terminated
- Initiated
- 2003-05-13
- Posted
- 2003-06-12
- Terminated
- 2003-09-15
- Reason
- Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
- Root cause
- Other
- Action
- On 5/13/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
- Quantity
- 83 units
- Distribution
- Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S. States include: MD, TN, TX, OH, and IL. The recall was appropriately extended to the user level; i.e., clinics, hospitals and medical centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
- Lot, serial or model codes
- Lot #: 28090403, 03-0085, 03-0086, C030401
- 510(k) numbers
- ["K022879"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3003515897
- Firm city
- Pleasanton
- Firm state
- CA
- 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