BVI has received two complaints from customers that identified an end of the sterile pouch of model #40430 PVA Ultracell Medical Sponges was not sealed. Two lots (21m3820 and 21l3403) have been identified as affected by this failure mode. BVI has determined through testing that the packaging sterile barrier has been compromised. This seal provides sterility for the product within the packaging. Open seals can lead to a loss of device sterility, which in turn may lead to infection. Recall start date: February 7, 2023
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