Integra MicroFrance Electrosurgical Instruments Recalled for Burn and Shock Risks
Integra LifeSciences is recalling 2,487 MicroFrance electrosurgical instruments due to reports of unintended patient or operator burns and electric shock.
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 is classified as FDA Class II and involves reports of burns and electric shock, which aligns with the rubric criteria for Severe severity involving significant injury reports.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,487 MicroFrance Monopolar and Bipolar Electrosurgical Instruments. The recall is being conducted because of reports of unintended patient or operator burns or operator electric shock associated with the use of these devices.
The affected instruments are identified by Catalogue No. CEV669E. The recall includes all batch numbers distributed from January 2011 to February 17, 2016. These products were distributed to facilities in Arkansas, California, Colorado, Florida, Indiana, Kentucky, Massachusetts, Michigan, North Carolina, New Jersey, New York, New Mexico, Ohio, Tennessee, Texas, Washington, and Wisconsin.
Healthcare providers and facilities should stop using the affected instruments and contact Integra LifeSciences Corp. for instructions on how to return the products or obtain a replacement.
The recalled product
- Product
- Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 2,487
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 (1)
- 2016.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corp. 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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