Z-1767-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- July 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,871 US; 18,670 worldwide
Product Description
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Reason for Recall
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries Canada and Australia.
Code Information
UDI-DI: 04058863080383 Lots 3000190535, 3000190536, 3000190537, 3000192076, 3000192077, 3000192078, 3000192079, 3000193358, 3000193359, 3000193360, 3000193361, 3000193362, 3000195061, 3000195062, 3000195063, 3000195064, 3000195065, 3000195066, 3000195067, 3000196193, 3000196195, 3000196196, 3000196197, 3000196198, 3000196199, 3000197830, 3000197831, 3000197833, 3000197837, 3000197839, 3000199069, 3000199071, 3000199072, 3000199073, 3000199074, 3000199077, 3000200108, 3000200110, 3000200111, 3000200112, 3000200113, 3000202025, 3000202027, 3000202029, 3000202030, 3000202031, 3000203092, 3000203093, 3000204058, 3000204156, 3000204157, 3000204284, 3000205878, 3000205879, 3000205880, 3000207510, 3000208687, 3000208692, 3000210629, 3000210630, 3000215200, 3000215238, 3000216174, 3000216177, 3000220057, 3000220062, 3000221755, 3000221756, 3000221757, 3000224126, 3000224134, 3000227577, 3000227580, 3000228336, 3000228337, 3000228338, 3000228804, 3000228805, 3000228864, 3000232543, 3000234522