CS Elite Fastpack recall
CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed…
Why was CS Elite Fastpack 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: CSE-FP-225V 1. Specific Lots with Bowl Cracks (7636 Distributed) Lot number: 1902009HTT 1903001HTT 1903004HTT 1804008HTT 1804010HTT 1805004HTT 1805005HTT 1812012HTT 1901004HTT 1901005HTT 1901006HTT 1808007HTT 1808009HTT 1808012HTT 1809001HTT 1809002HTT 1809006HTT 1809009HTT 1810001HTT 1810003HTT 1901005HTT 1902009HTT 1810006HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
- Product
- CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed…
- Recalling firm
- Haemonetics Corporation
- Quantity
- 42739
- 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)