The manufacturer shipped outer corrugated boxes to the contract sterilizer that include inner boxes that are addressed to the end customer.The company shipped the sterilizer 6 of these outer boxes, but the sterilizer only received 5 out of the 6 boxes.The company waited several days to see if the 6th box would arrive at the sterilizer, but it never did.At that point, the company initiated a claim with (b)(6).In looking at the (b)(6) records, the outer package was received at a (b)(6) facility on 12/21.On the 22nd, the inner boxes were picked up from that (b)(6) location and shipped to the customers.It is unknown why the outer box (addressed to the sterilizer) was opened by (b)(6) to expose the 3 inner boxes.As soon as the company was aware that non-sterile components had been delivered to the end users they reached out to instruct the facilities to immediately quarantine the devices and ship them back to the manufacturer as soon as possible.Two of the three sites who had received the non-sterile product had used at least one of the devices.The facility was able to narrow it down to several patients who could have been exposed but not the exact single patient.
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