Other Medical Devices

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Complaints have been received with allegations of Incorrect Needle Curvature.

Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

Patient support table floor plate may be incorrectly installed.