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Terminated

Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-212

FDA Recall Z-0738-03 · Posted 2003-04-17

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeGBM
Date Initiated2003-03-17
Date Terminated2016-03-07
Product Quantity47 boxes (20 units/box)

Reason for Recall

Warning flag may be detached from the tip protector on thel catheter and result in the tip protector advancing through the catheter during use

Firm Action

Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.

Root Cause

Other

Distribution Pattern

Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K870694VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETERVan-Tec, Inc. · 1987-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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