Z-0889-2020 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
- 1340
Product Description
CS5/5+ Fastpacks, 125 mL, 20¿ 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: 0265F-00 1. No specific lots with bowl cracks. 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.