ClearanceBrief
Recall Z-0899-2020 ยท CAC Apparatus, Autotransfusion

Haemonetics Corporation

JAPAN DISP SET, 261J, 205J, 208 - 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. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorpore

DateOct 21, 2019
StatusTerminated
ReasonPotential 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.
Root causeDevice Design
ActionOn October 21 & 22, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail: SAFETY NOTIFICATION FOR 125ml and 225ml Centrifuge Bowls Attention: Risk Management Director, Materials Manager and Director Biomedical Engineering Please forward this communication to all potential users of the products. Dear Customer, Haemonetics makes continuous efforts to supply our customers with products that meet the highest levels of product quality and reliability. We have recently identified a potential issue with Cell Saver 5/5+ and Cell Saver Elite/Elite + 125ml and 225ml bow
Quantity25529
DistributionWorldwide 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.