BioPro recalled 147 bipolar heads due to a potential packaging issue that may compromise sterility. The defect could result in infection if the device is implanted. Patients and healthcare providers must stop using the device immediately and follow recall instructions.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioPro, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The BioPro Bipolar Head is a specialized medical device used in electrosurgery to cut and coagulate tissue. Healthcare providers depend on the sterilization integrity of these devices to prevent infections during surgical procedures.
The potential packaging issue can lead to the device losing its sterile barrier, which increases the risk of infection if implanted in a patient.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act quickly to prevent the risk of infection associated with the use of potentially contaminated devices.
Serial numbers and product IDs can usually be found on the packaging or labeling of the device.
Expect a refund or replacement processing time of 4-8 weeks.
Keep records of your purchase, including receipts and any correspondence related to the recall.
Product IDs: 18130 (38MM) through 18152 (60MM). Total quantity: 147 units. Distributed in Texas and Michigan.
No injuries or incidents have been reported.
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