Recalls / —

—#28238

Product

ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394

Affected lot / code info

4105648 4113988 4162641 4193798 4206664 4231542 4266299 4290089 4297846 4339339 4363204 4387477 4401411 4414613 4472494 4494612 4506626 4528577 4555320 4591333 4611363 4646473 4671080 4732694 4776718 4792615 4814439 4916050 4923749 4940371 4955250 5000456 5025458 5048339 5071211 5086862 5153158 5190439 5226638 5280768 5313310 5340135 5343856 5347420 5374497 5388620 5395693 5446265

Why it was recalled

Sterility of the device may b e 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 #28238. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.