Additional information: h4 - manufacture date.H3 and h6 - evaluation codes: updated.Device evaluation: one (1) unit received with original package.Two photos were also submitted.Picture one shows an l-70 device, picture two shows a return connector.In the inspected sample, delamination is observed at the junction of the return connector and the tube which could cause leakage.The unit failed the leak test.The reported failure mode is confirmed.Based on the analysis on the returned unit, and review of the mitigations during the manufacturing process, the root cause of the lack of solvent.Awareness notification for failure mode reported to production personnel was issued.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
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