FDA (Devices) recall action 97604
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
IV sets may leak.
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.
Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots because the IV sets may leak.
Baxter is recalling 49,200 Continu-Flo solution sets with a 4-way stopcock extension set because the IV sets may leak.
Baxter is recalling 473,040 CLEARLINK System Continu-Flo solution sets across six lots because the IV sets may leak.
Baxter is recalling 48,096 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.
Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.
Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.
Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.
Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.
Baxter is recalling 12,720 CLEARLINK System Continu-Flo solution sets with three luer activated valves from one lot because the IV sets may leak.
Baxter is recalling 106,176 CLEARLINK System Continu-Flo solution sets with a 0.2 micron filter from one lot because the IV sets may leak.
Baxter is recalling 958,351 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
Baxter is recalling 2,304 CLEARLINK System straight-type extension sets with a retractable collar from one lot because the IV sets may leak.
Baxter is recalling 27,072 CLEARLINK System Paclitaxel Sets from one lot because the IV sets may leak.
Baxter is recalling 18,720 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.
Baxter is recalling 136,512 CLEARLINK System DUO-VENT solution sets across three lots because the IV sets may leak.