BioPro, Inc.: BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Domestic distribution to Texas and Michigan. Quantity: 147 total Lot/code info: Product ID/UDI-DI 18130 M20918130 18131 M20918131 18132 M20918132 18133 M20918133 18134 M20918134 18135 M20918135 18136 M20918136 18137 M20918137 18138 M20918138 18139 M20918139 18140 M20918140 18141 M20918141 18142 M20918142 18143 M20918143 18144 M20918144 18145 M20918145 18146 M20918146 18147 M20918147 18148 M20918148 18149 M20918149 18150 M20918150 18151 M20918151 18152 M20918152 All lots, all serial numbers

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.