ConMed Recalls Electrosurgical Tip Cleaners Due to Compromised Sterile Seals
ConMed is recalling 313,190 Electrosurgical Tip Cleaners because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
ConMed Corporation is recalling 313,190 units of Electrosurgical Tip Cleaners (REF/Catalog No. 138029). These single-use, sterile devices are distributed worldwide, including in the United States, Puerto Rico, and various international locations.
The recall was initiated after ConMed received complaints that some devices had broken through the seal of the sterile pouch. The company confirmed that the pouch seals were compromised on the affected products. The compromised seals were discovered prior to use.
ConMed has not reported any instances where the sterile barrier compromise resulted in illness or injury. The affected lot codes range from 120628X to 120725X.
The recalled product
- Product
- Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
- Manufacturer
- ConMed Corporation
- Affected units
- 313,190
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Beginning Lot Code 120628X
- 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)].
Distribution
Part of a larger recall action
This product is one of 20 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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