CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product recall
CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and…
Why was CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number/FG Item Number: 00261-00 1. Specific Lots with Bowl Cracks (8111 Distributed) Lot numbers: 0119008 0719045 0819016 1118051 1118006 0919022 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
- Product
- CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and…
- Recalling firm
- Haemonetics Corporation
- Quantity
- 333443
- Distribution
- 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.
- Recall date
- February 5, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)