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Terminated

Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA

FDA Recall Z-0260-2008 · Posted 2007-11-24

Recalling FirmBoston Scientific Target
Recall StatusTerminated
Product CodeDQY
Date Initiated2007-07-11
Date Terminated2007-12-05
Product Quantity49 units

Reason for Recall

Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)

Firm Action

Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980453SCHNEIDER GUIDER SOFTIP GUIDING CATHETERSBoston Scientific Scimed, Inc. · 1998-08-11

Official Source

View FDA Recall →

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

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