Z-0896-2020 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
- 14698
Product Description
CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - 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.
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-FP-125V 1. Specific Lots with Bowl Cracks (959 Distributed) Lot numbers: 1902003HTT 1902002HTT 1909003HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.