Recall Z-0941-2007 ยท KNQ Dilator, Esophageal
Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
| Date | Jun 19, 2007 (initiated Apr 16, 2007) |
| Status | Terminated |
| Reason | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| 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 | 3,826 units (#000345) and 41 units (#000736). |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033936 | BARD ELIMINATOR PET BALLOON DILATORS C.R. Bard, Inc., Jan 14, 2004 |