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Terminated

EBI VueCath Endoscopic Spinal System

FDA Recall Z-1006-03 · Posted 2003-07-15

Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeGWG
Date Initiated2003-06-17
Date Terminated2003-12-31
Product Quantity39

Reason for Recall

Non sterile device is labeled sterile.

Firm Action

The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.

Root Cause

Labeling False and Misleading

Distribution Pattern

Hospitals, clinics, and doctors nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023233EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEMEbi, L.P. · 2002-12-13K010179EBI VUECATH SPINAL ENDOSCOPIC SYSTEMEbi, L.P. · 2001-02-09K982484EBI VUECATH ENDOSCOPIC SPINAL SYSTEMElectro-Biology, Inc. · 1998-10-08K971083ARTHROSCOPEElectro-Biology, Inc. · 1997-06-23

Official Source

View FDA Recall →

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

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