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U.S. Department of Health and Human Services

Class 2 Device Recall CS Elite Fastpack

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  Class 2 Device Recall CS Elite Fastpack see related information
Date Initiated by Firm October 21, 2019
Create Date January 29, 2020
Recall Status1 Terminated 3 on November 06, 2020
Recall Number Z-0895-2020
Recall Event ID 84183
510(K)Number K101907  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.
Code Information 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.
Recalling Firm/
Manufacturer		 Haemonetics Corporation
400 Wood Rd
Braintree MA 02184-2412
For Additional Information Contact
781-848-7100
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On October 21 & 22, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail: SAFETY NOTIFICATION FOR 125ml and 225ml Centrifuge Bowls Attention: Risk Management Director, Materials Manager and Director Biomedical Engineering Please forward this communication to all potential users of the products. Dear Customer, Haemonetics makes continuous efforts to supply our customers with products that meet the highest levels of product quality and reliability. We have recently identified a potential issue with Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ + 125ml and 225ml bowl sets. The investigation has determined that a small number of bowl sets may have the potential to develop leaks at the inner core, which could result in fluid becoming trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. Note: The likelihood of experiencing an inner core leak is low, and no fluid has been found to exit the bowl into the Cell Saver device. We have a dedicated team implementing corrective actions to resolve this issue. What to do if experiencing Long Empty error code on your device: If an error code indicates Long Empty, complete the troubleshooting guidance provided on Page 3 in this communication. If the error message continues, the user should remove the bowl, tilt it upside down and visually check the base for cracks directly on or extending from the ribs. See Page 4 for photo example of where to inspect: -If no cracks are observed and procedure is complete, proceed with using the blood in the reinfusion bag. No further action is required. If continuing with the procedure, use a new processing set. - If cracks are confirmed, the user should assume incomplete washing of the bowl contents, and the wash cycle should be repeated on blood that is in the reinfusion bag. Take any residual RBCs in the reinfusion bag, and empty its contents into the cardiotomy reservoir to rep
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = HAEMONETICS CORP.
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