Recalls / —

—#28048

Product

Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557

510(k) numbers

K991056

Affected lot / code info

Lot Number: 5404484

Why it was recalled

Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Place, Natick, Massachusetts 01760

Distribution

Distribution pattern

CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea

Timeline

Recall initiated

2003-06-26

Posted by FDA

2003-07-15

Terminated

2005-04-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #28048. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.