Recall Z-0893-2020
Haemonetics Corporation · initiated October 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CS Elite Processing Set (125 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.
Codes / lots: Catalog number/FG Item Number: CSE-P-125 1. Specific Lots with Bowl Cracks (10856 Distributed) Lot number: 0119014 0119015 0719047 0719060 0819014 0819032 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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: Device Design
Action taken
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
Details
- Recall number
- Z-0893-2020
- Initiated
- October 21, 2019
- Terminated
- November 6, 2020
- Product code
- CAC – Apparatus, Autotransfusion
- Quantity
- 176742
- 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.
- Recalling firm
- Haemonetics Corporation, Braintree, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0885-2020 Class II | CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0886-2020 Class II | CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0887-2020 Class II | High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0888-2020 Class II | CS5/5+ Fastpacks, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0889-2020 Class II | CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0890-2020 Class II | CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0891-2020 Class II | Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0892-2020 Class II | CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0894-2020 Class II | CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0895-2020 Class II | CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0896-2020 Class II | CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0897-2020 Class II | JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0898-2020 Class II | JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0899-2020 Class II | JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0900-2020 Class II | JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0901-2020 Class II | Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0902-2020 Class II | JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0903-2020 Class II | JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0904-2020 Class II | JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0905-2020 Class II | Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0906-2020 Class II | Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |