Electrosurgical Tip Cleaner recall: Sterility Concern
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Why was Electrosurgical Tip Cleaner recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Beginning Lot Code 120628X, Ending Lot Code 120725X. [Lot codes on boxes and packaging contain a lot code in the following form: 120725X where 12 represents the year (2012), 07 represents the month (July), 25 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
- Product
- Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
- Recalling firm
- ConMed Corporation
- Quantity
- 313,190 (total for all devices)
- 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 date
- January 30, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)