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Terminated

ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.

FDA Recall Z-1160-06 · Posted 2006-06-22

Recalling FirmSuros Surgical Systems Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2006-05-25
Date Terminated2007-03-12
Product Quantity939

Reason for Recall

Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).

Firm Action

Consignees were notified telephone and letter dated 5/25/06 to stop using the recalled product and to return it to the firm. The recall was extended to an additional lot by phone calls to each customer between Julne 26 and 30, 2006 and by letter dated 6/19/06 and sent between June 28 and July 7, 2006.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010400VACUUM ASSISTED CORE BIOPSY DEVICEPromex, Inc. · 2001-07-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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