FDA (Devices) recall action 84365
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Potential for leakage at the joint between the blood filters and tubing
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 1,050 Y-Type Blood Sets because they may leak at the joint between the blood filters and tubing.
B. Braun Medical is recalling 2,736 Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.
B. Braun Medical is recalling 1,824 Outlook Safety Infusion System Y-type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.
B. Braun Medical is recalling 9,000 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.
B. Braun Medical is recalling 3,300 units of Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.
B. Braun Medical is recalling 19,500 Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.
B. Braun Medical is recalling 5,616 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.