Z-0935-03

Sanarus brand Centrica Rotational Core Biopsy medical device, Model/

Name: Z-0935-03 Sanarus brand Centrica Rotational Core Biopsy medical device, Model/
Creator: Sanarus Medical Inc
Published: 2003-05-13
License: https://open.fda.gov/license/

Sanarus Medical, Inc. / initiated 2003-05-13 / Terminated

FDA source

Sanarus Medical Inc began a recall of Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack) on 2003-05-13. The reason FDA records is "Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0935-03
Status: Terminated
Initiated: 2003-05-13
Posted: 2003-06-12
Terminated: 2003-09-15
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)
Product code: KNW Instrument, Biopsy
Reason for recall: Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
FDA 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 in commerce: 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.
Product codes and lots: Lot #: 28090403, 03-0085, 03-0086, C030401

Product code KNW

K022879Class IIModification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. / cleared 2002-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)