Z-0938-2007

ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product...

Name: Z-0938-2007 ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product...
Creator: Conmed Endoscopic Technologies, Inc.
Published: 2007-04-16
License: https://open.fda.gov/license/

Conmed Endoscopic Technologies, Inc. / initiated 2007-04-16 / Terminated / root cause: labeling and UDI

FDA source

Conmed Endoscopic Technologies, Inc. began a recall of ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile... on 2007-04-16. The reason FDA records is "Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0938-2007
Status: Terminated
Initiated: 2007-04-16
Posted: 2007-06-19
Terminated: 2010-07-30
Recalling firm: Conmed Endoscopic Technologies, Inc.
Product: ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
Product code: KNQ Dilator, Esophageal
Reason for recall: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 414 units.
Distribution: 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.
Product codes and lots: All lots manufactured from May 03, 2006 to December 14, 2006 which includes lot numbers/codes from 0605031 to 0612141. Lot code identification is as follows: For lot #0605031: 06 = year (2006); 05 = month (May); 03 = Day of Month (3rd); 1 = Manufacturing Shift Code (1st shift).

Product code KNQ

K033936Class IIBard Eliminator Pet Balloon DilatorsC.R. Bard, Inc. / cleared 2004-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)