FDA Enforcement
Class II
Ongoing
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Recall: Z-2342-2024
·
Reported July 17, 2024
Enforcement
- Recall Number
- Z-2342-2024
- Event ID
- 94775
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2024
- Initiation Date
- June 3, 2024
- Classification Date
- July 11, 2024
- Address
- 920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States
Description
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Reason
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.
Code Info
Model Number: 191014; UDI/DI: N/A (Canada only); Serial Number: 6K0S162351, 6K0S162352, 6K0S162353, 6K0S162354, 6K0S162355, 6K0S169113, 6K0S169114, 6K0S169115, 6K0S169116, 6K0S169117, 6K0S169118, 6K0S169119, 6K0S169120, 6K0S169121, 6K0S169122, 6K0S169123, 6K0S169124, 6K0S169125, 6K0S169126, 6K0S169127.
Distribution
Domestic: Nationwide Distribution. International: Canada.
Quantity
20 units (all OUS)