Z-1063-03

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

Name: Z-1063-03 ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394
Creator: Boston Scientific Corporation
Published: 2003-07-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-07-03 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394 on 2003-07-03. The reason FDA records is "Sterility of the device may b e compromised due to a lack of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1063-03
Status: Terminated
Initiated: 2003-07-03
Posted: 2003-07-29
Terminated: 2004-06-17
Recalling firm: Boston Scientific Corporation
Product: ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394
Reason for recall: Sterility of the device may b e compromised due to a lack of package integrity
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 2505 units
Distribution: Nationwide
Product codes and lots: 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

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)