ConMed Recalls MACROLYTE Premie Dispersive Electrodes Due to Sparking and Burning
ConMed Corporation is recalling MACROLYTE Premie Dispersive Electrodes due to confirmed complaints of sparking, no output, and burning at the cord set connection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with confirmed reports of burning and sparking, which constitutes a significant injury risk under the rubric for Severe severity.
Plain-English summary
ConMed Corporation is recalling the MACROLYTE Premie Dispersive Electrode, Reference 440-2400. This medical device is applied to patients during electrosurgical procedures to provide a path for radiofrequency current to leave the patient and return to the generator.
The recall was initiated after ConMed received and confirmed complaints regarding sparking, no output, and burning at the cord set connection. The affected units were distributed worldwide, including the United States and numerous international markets.
Healthcare providers and consumers should stop using the affected devices immediately. The recall covers units with lot codes beginning with 1204275 and ending with 1401075. The lot code indicates the date of manufacture in the format yymmdds, where s represents the shift.
The recalled product
- Product
- MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
- Manufacturer
- ConMed Corporation
- Hazard
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 (3)
- Beginning Lot Code 1204275
- Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds
- where s is the shift).
Distribution
Distributed nationwide across the United States.
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