Integra LifeSciences Recalls Codman ISOCOOL Bipolar Forceps Due to Insulation Defect
Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.
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 3/5 (High).
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 is classified as FDA Class II. The hazard involves a surgical device failing to coagulate tissue as expected, which poses a risk of harm during surgery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 125 units of Codman ISOCOOL Bipolar Forceps, Model # 8145100S, Lot # J2670Y. These medical devices are indicated for cauterizing, coagulating, grasping, and manipulating tissue during various surgical procedures, including general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial or plastic surgery.
The recall is being issued because the tips of the forceps have an inadequate product insulation coating. This defect could result in the tips not coagulating as expected during use. The affected units were distributed to Kentucky, New Jersey, Rhode Island, Texas, Washington, and Belgium.
Healthcare facilities and consumers should stop using the affected forceps immediately. Users should contact the manufacturer for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 125
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)
- Lot # J2670Y
Distribution
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