Recalls / —

—#28236

Product

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

FDA product code

KNW — Instrument, Biopsy

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K935814

Affected lot / code info

4104836, 4145036, 4211323, 4290090 ,4370503 4405122, 4445839, 4461241, 4569317, 4666229 4916051, 5022356, 5120746, 5133248, 5251508,  5288530

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Place, Natick, Massachusetts 01760

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2003-07-03

Posted by FDA

2003-07-29

Terminated

2004-06-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #28236. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.