CS5/5+ Fastpacks recall
CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery…
Why was CS5/5+ Fastpacks 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: 00260-00 1. Specific Lots with Bowl Cracks (6920 Distributed) Lot numbers: 1907006HTT 1902005HTT 1902008HTT 1902011HTT 1906005HTT 1803013HTT 1804004HTT 1804006HTT 1804002HTT 1804009HTT 1805002HTT 1805003HTT 1811002HTT 1812010HTT 812011HTT 1901001HTT 1812005HTT 1812008HTT 1901007HTT 1808006HTT 1808010HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
- Product
- CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery…
- Recalling firm
- Haemonetics Corporation
- Quantity
- 44821
- 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)