Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
Check against the official notice below — it lists the full affected range.
Haemonetics Corporation has recalled Japan DISP SET models 263J and 205J, which are accessory components used with Cell Saver blood recovery and processing devices. The recall affects 1,584 units distributed nationwide across all U.S. states and internationally to Australia, New Zealand, India, Pakistan, the Philippines, Hong Kong, Vietnam, Malaysia, Indonesia, Singapore, China, Austria, Germany, France, Great Britain, Italy, and Switzerland. These bowl sets for Cell Saver 5/5+, Elite, and Elite+ devices (in 125ml and 225ml sizes) may develop leaks at the inner core that can trap fluid inside, potentially causing a "long empty" error message and incomplete washing of the device. The affected products were manufactured between October 2014 and October 2019, with specific lot numbers identified as having bowl cracks. Some units also lacked instructions to check for cracks in their manuals.
The source document does not specify what consumers or healthcare facilities should do if they have one of these recalled products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH. Quantity: 1584 Lot/code info: Catalog number/FG Item Number: 263J-SS-SET 1. Specific Lots with Bowl Cracks (110 Distributed) Lot number: 0718027-0119029-08170710119003; 0718027-0818086-08170711018045; 0718027-1118031-08170711118019; 0718027-1118081-08170710119084 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.