Z-0892-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- October 21, 2019
- Termination Date
- November 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 257345
Product Description
CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.
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 Pattern
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.
Code Information
Catalog number/FG Item Number: CSE-P-225 1. Specific Lots with Bowl Cracks (37248 Distributed) Lot numbers: 0718008 0818052 0818110 0119048 0218064 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.