FDA (Devices) recall action 83478
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
The filter capacity is not achieved due to damage of the filter membrane.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
B. Braun Medical is recalling 960 epidural trays because filter membrane damage prevents the filter from achieving its intended capacity.
B. Braun Medical is recalling 540 units of CE17TKN epidural Tuohy needle filters because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.
B. Braun Medical is recalling 100 units of Espocan Spinal/Epidural Trial Needles because damage to the filter membrane prevents the filter from achieving its intended capacity.
B. Braun Medical is recalling 200 units of Con Epi Trays because damage to the filter membrane prevents the device from achieving its required filter capacity.
B. Braun Medical is recalling 1,230 units of CE18TKSTN Cont. Epidural Needles because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.
B. Braun Medical is recalling 3,820 units of Accu-Bloc Perifix Kits because damage to the filter membrane prevents the device from achieving its intended filter capacity.
B. Braun Medical is recalling 200 units of Accu-Bloc Perifix Kits because damaged filter membranes may prevent the device from achieving required filter capacity.
B. Braun Medical is recalling 250 units of FEF 100N Flat Epidural Filters because damage to the filter membrane prevents the device from achieving its intended filter capacity.
B. Braun Medical is recalling 200 units of spinal and epidural trays because the filter membrane is damaged, preventing the device from achieving required filter capacity.