Recalls / —

—#28237

Product

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

Affected lot / code info

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

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 #28237. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.