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Terminated

Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030

FDA Recall Z-0696-2007 · Posted 2007-03-31

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKOG
Date Initiated2007-02-07
Date Terminated2007-11-15
Product Quantity115 units

Reason for Recall

SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

Firm Action

Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

Root Cause

Other

Distribution Pattern

Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052194SPYGLASS DIRECT VISUALIZATION PROBE AND OCULARBoston Scientific Corp · 2005-08-24

Official Source

View FDA Recall →

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

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