| Class 2 Device Recall CS Elite | |
Date Initiated by Firm | October 21, 2019 |
Create Date | January 29, 2020 |
Recall Status1 |
Terminated 3 on November 06, 2020 |
Recall Number | Z-0892-2020 |
Recall Event ID |
84183 |
510(K)Number | K101907 |
Product Classification |
Apparatus, autotransfusion - Product Code CAC
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Product | CS Elite Processing Set (225 ml) 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-P-225 1. Specific Lots with Bowl Cracks (37248 Distributed) Lot numbers: 0718008 0818052 0818110 0119048 0218064 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
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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 | 257345 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = CAC
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