ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall Z-0949-2007 · Posted 2007-06-19
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Recalling FirmConmed Endoscopic Technologies, Inc.
Recall StatusTerminated
Product CodeKNQ
Date Initiated2007-04-16
Date Terminated2010-07-30
Product Quantity239 units (#000861) and 12 units (#000867).
Reason for Recall
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Firm Action
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning product.
Root Cause
Other
Distribution Pattern
Worldwide-Devices distributed to medical facilities and distributors Nationwide (USA) and to distributors in the following countries: Australia, Belgium, Canada, Croatia, Denmark, Germany, India, Italy, Japan, Mexico, Poland, Spain and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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