Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
FDA Recall Z-0935-03 · Posted 2003-06-12
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Recalling FirmSanarus Medical Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2003-05-13
Date Terminated2003-09-15
Product Quantity83 units
Reason for Recall
Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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