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Terminated

ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250

FDA Recall Z-1061-03 · Posted 2003-07-29

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKNW
Date Initiated2003-07-03
Date Terminated2004-06-17
Product Quantity1,030 units

Reason for Recall

Sterility of the device may be compromised due to a lack of package integrity

Firm Action

Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935814MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLEBoston Scientific Corp · 1994-03-14

Official Source

View FDA Recall →

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

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