Recall Z-1868-2024
Fresenius Medical Care Holdings, Inc. · initiated April 17, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Codes / lots: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191126, UDI/DI: 00840861102099; Serial Numbers: 3T0S270687, 3T0S270700, 3T0S274007, 3T0S274009, 3T0S274011, 3T0S274012, 3T0S274016, 3T0S274057, 3T0S274859, 3T0S274920, 3T0S274922, 3T0S274923, 3T0S274938, 3T0S274957, 3T0S274969, 3T0S274970, 3T0S274980, 3T0S274985, 3T0S274996, 3T0S274997, 3T0S275004, 3T0S275009, 3T0S275011, 1T0S262226, 1T0S262249, 1T0S262254, 1T0S262257, 1T0S262265, 1T0S262266, 1T0S262267, 1T0S262268, 1T0S262269, 1T0S262272, 1T0S262273, 1T0S262274, 1T0S262275, 1T0S262276, 1T0S262278, 1T0S262279, 1T0S262280, 1T0S262282, 1T0S262283, 1T0S262284, 1T0S262285, 1T0S262286, 1T0S262289, 1T0S262293, 1T0S262294, 1T0S262296, 1T0S262297, 1T0S262299, 1T0S262300, 1T0S262305, 1T0S262313, 1T0S262315, 1T0S262319, 1T0S262321, 4T0S275623, 4T0S275627, 4T0S275628, 4T0S275629, 4T0S275639, 4T0S275649, 4T0S275654, 4T0S275662, 4T0S275664, 4T0S275666, 4T0S275677, 4T0S275682, 4T0S275685, 4T0S275688, 4T0S275692, 4T0S275703, 4T0S275729, 4T0S275738, 4T0S275742, 4T0S275745, 4T0S275760, 4T0S275768, 4T0S275769, 4T0S275778, 4T0S275787, 4T0S275800, 4T0S275804, 4T0S276804, 4T0S276814, 4T0S276818…
Reason for recall
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
FDA-determined cause: Device Design
Action taken
On April 17, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer actions: As per the 2008T Operators Manual P/N 490122 Rev AA: Blood Pump Rotors should be inspected for proper operation, as stated in Chapter 2: Daily preparation for treatment. If you experience a dislodged guide post sleeve, bent or loose tubing guide posts, or roller cannot move freely on your current F40015481 Rev A blood pump rotor, please contact FMCRTG Technical Support Services at 800-405-1321 for a replacement Blood Pump Rotor (Part Number, F40015481, Rev C) . Have Rotor Lot Number available when requesting a replacement. Please provide this letter to your Biomedical Technician or trained personnel. Report any complaints or adverse events to product.complaints@fmc-na.com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. Provide this Customer Notice to all those who need to be aware within your organization. Complete and return the attached reply form. Biomedical Technician/ actions: A Field Service Bulletin will be posted to fmcna.com website regarding Preventative Maintenance activities for Blood Pump Rotor Tubing Guide Inspection of the need to inspect the blood pump tubing guides during the 6-month Preventive Maintenance on all 2008 Series Hemodialysis Machines. URL: https://fmcna.com/support/product-support-documents/field-service-bulletins/ For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Details
- Recall number
- Z-1868-2024
- Initiated
- April 17, 2024
- Posted by FDA
- May 17, 2024
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Quantity
- 12,292 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1866-2024 Class II | Blood Pump Rotor, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | 04/17/2024Open, Classified |
| Z-1867-2024 Class II | 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | 04/17/2024Open, Classified |
| Z-1869-2024 Class II | 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | 04/17/2024Open, Classified |
| Z-1870-2024 Class II | 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | 04/17/2024Open, Classified |