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TSE Brake (TSE) is recalling certain Omni Tandem Brake Chambers part number 2024TLD2-1946. The spring brake chamber may have been assembled with incorrect springs that were out of specification, which can cause the pressure plate to shift.
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection