High Speed Cell Saver¿5/5+ Bowl Set 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.
Enforcement
- Recall Number
- Z-0887-2020
- Event ID
- 84183
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Haemonetics Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 5, 2020
- Initiation Date
- October 21, 2019
- Classification Date
- January 29, 2020
- Termination Date
- November 6, 2020
- Address
- 400 Wood Rd, N/A, Braintree, MA, 02184-2412, United States
Description
High Speed Cell Saver¿5/5+ Bowl Set 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.
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.
Catalog number/FG Item Number: 0263A-00 1. No lots for cracking issue identified (0 Distributed). 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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.
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