ConMed Corporation Recall: UltraClean(R) Accessory Electrode 6 inch Coated Needle with Ext
ConMed Corporation Recall: UltraClean(R) Accessory Electrode 6 inch Coated Needle with Ext is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: ConMed Corporation; Product: UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, S
| Recalling firm | ConMed Corporation |
|---|---|
| Product | UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. |
| Reason for recall | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay. |
| Recall initiated | 20121227 |
| Recall number | Z-0734-2013 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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