Z-1061-03

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

Name: Z-1061-03 ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250
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, 14 gauge Reference Number: 1250 on 2003-07-03. The reason FDA records is "Sterility of the device may be 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-1061-03
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, 14 gauge Reference Number: 1250
Product code: KNW Instrument, Biopsy
Reason for recall: Sterility of the device may be 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: 1,030 units
Distribution: Nationwide
Product codes and lots: 4104836, 4145036, 4211323, 4290090 ,4370503 4405122, 4445839, 4461241, 4569317, 4666229 4916051, 5022356, 5120746, 5133248, 5251508, 5288530

Product code KNW

K935814Class IIMicrovasive(r)/meditech(r) Asap(tm) 14G Biopsy NeedleBoston Scientific Corp / cleared 1994-03-14

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)