Z-1062-03

ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390

Name: Z-1062-03 ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390
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, 15 gauge Reference Number: 1390 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-1062-03
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, 15 gauge Reference Number: 1390
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: 9455 units
Distribution: Nationwide
Product codes and lots: 4097154 4126946 4145035 4158456 4193792 4212753 4221510 4231545 4256164 4262043 4258584 4282986 4313907 4323261 4349628 4375687 4392520 4405118 4408527 4414677 4425997 4464404 4464403 4468969 4494611 4528589 4537936 4550692 4557360 4562655 4579693 4583642 4625634 4628069 4639625 4652811 4689625 4701139 4701138 4727026 4742360 4764119 4764122 4774555 4788365 4823397 4830419 4845754 4900789 4910488 4915451 4935096 4963935 4963936 4983393 4992627 5007857 5019451 5022419 5038639 5065152 5121437 5129514 5140440 5155296 5158742 5169243 5173373 5182914 5186852 5205601 5223778 5227258 5238638 5246424 5251510 5269078 5288531 5301576 5320588 5371233 5427428 5440613 5473223 5501877 5505775 5511863 5547602

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)