FDA (Devices) recall action 84183
The FDA (Devices) publishes a recall like this one as 22 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 22 pages.
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
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.
Haemonetics is recalling Cell Saver 5/5+ Bowl Kits because they may leak, trapping fluid and causing incomplete washing.
Haemonetics is recalling CS5/5+ Bowl Kits because potential leaks may trap fluid, causing device errors and incomplete washing.
Haemonetics is recalling specific Japan Disp Sets for Cell Saver systems due to potential bowl cracks that may cause leaks and incomplete blood washing.
Haemonetics is recalling CS Elite Processing Sets (125 ml) because cracks in the bowl core may cause fluid trapping and incomplete blood washing.
Haemonetics is recalling specific Cell Saver bowl sets because they may leak, potentially trapping fluid and causing incomplete washing.
Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete washing.
Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because they may leak, trapping fluid and causing incomplete washing.
Haemonetics is recalling Cell Saver Elite sets because potential leaks in the bowl core may cause fluid trapping and incomplete washing.
Haemonetics is recalling Cell Saver 5/5+ Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete washing.
Haemonetics is recalling CS5/5+ Fastpacks because cracks in the bowl core may trap fluid, causing device errors and incomplete washing.
Haemonetics is recalling Cell Saver Elite sets because cracks in the bowl core may trap fluid, causing incomplete washing of recovered blood.
Haemonetics is recalling 1,340 units of Cell Saver 5/5+ Fastpacks because potential leaks in the inner core may cause fluid trapping and incomplete washing.
Haemonetics is recalling 8,641 Cell Saver 5/5+ Fastpacks because cracks in the bowl core can trap fluid, causing incomplete washing and device errors.
Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.
Haemonetics is recalling Cell Saver bowl sets because cracks may cause leaks and incomplete blood washing.
Haemonetics is recalling 739 Cell Saver bowl sets because cracks in the inner core can cause leaks and incomplete blood washing.
Haemonetics is recalling 1,584 Japan DISP SETs because cracks in the bowl core may cause leaks and incomplete washing.
Haemonetics is recalling CS Elite Processing Sets because cracks in the bowl core may cause fluid trapping and incomplete washing.
Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.
Haemonetics is recalling Cell Saver Elite Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete blood washing.
Haemonetics is recalling Cell Saver bowl sets because cracks in the inner core may cause leaks and incomplete blood washing.
Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because potential leaks may trap fluid, causing incomplete washing of recovered blood.