Z-0033-2024 Class I Ongoing
FDA device recall Z-0033-2024 was initiated by Fresenius Medical Care Holdings, Inc. on September 6, 2023 and is designated Class I. Reason for recall: Potential PCBA leaching from tubing of hemodialysis machines. The recall status is ongoing. Affected quantity: 733 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- September 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 733 units
Product Description
2008T HD SYS. CDX W/BIBAG BLUESTAR
Reason for Recall
Potential PCBA leaching from tubing of hemodialysis machines.
Distribution Pattern
Domestic: Nationwide Distribution.
Code Information
Model No: 191126; UDI-DI: 00840861102099; Serial No. 1T0S261032, 1T0S261004, 1T0S261029, 1T0S260995, 1T0S260937, 1T0S260739, 1T0S260687, 1T0S260573, 2T0S263945, 2T0S263947, 2T0S263959, 2T0S263924, 2T0S263962, 2T0S263956, 2T0S263951, 2T0S263950, 2T0S263707, 2T0S263692, 2T0S263690, 2T0S263682, 2T0S263700, 2T0S264084, 2T0S263944, 2T0S263954, 2T0S263957, 2T0S264087, 2T0S264144, 2T0S264132, 2T0S264073, 2T0S264139, 2T0S264061, 2T0S263979, 2T0S263983, 2T0S263973, 2T0S263977, 2T0S263989, 2T0S263938, 2T0S263960, 2T0S263943, 2T0S263968, 2T0S263941, 2T0S263940, 2T0S263939, 2T0S263934, 2T0S263933, 2T0S263932, 2T0S263931, 2T0S263930, 2T0S263927, 2T0S263926, 2T0S263925, 2T0S263923, 2T0S263922, 2T0S263921, 2T0S263920, 2T0S263919, 2T0S263918, 2T0S263916, 2T0S263912, 2T0S263911, 2T0S263910, 2T0S263792, 2T0S263791, 2T0S263784, 2T0S263780, 2T0S263778, 2T0S263776, 2T0S263775, 2T0S263771, 2T0S263769, 2T0S263767, 2T0S263754, 2T0S263752, 2T0S263721, 2T0S263715, 2T0S263711, 2T0S263703, 2T0S263948, 2T0S263718, 2T0S263935, 2T0S263946, 2T0S263953, 2T0S263785, 2T0S263710, 2T0S263615, 2T0S264240, 2T0S264210, 2T0S264246, 2T0S264220, 2T0S264243, 2T0S264250, 2T0S264211, 2T0S264221, 2T0S264247, 2T0S264255, 2T0S264245, 2T0S264248, 2T0S264241, 2T0S264249, 2T0S264264, 2T0S264258, 2T0S264232, 2T0S264234, 2T0S264235, 2T0S264259, 2T0S264265, 2T0S264263, 2T0S264260, 2T0S264227, 2T0S264226, 2T0S264229, 2T0S264224, 2T0S264230, 2T0S264231, 2T0S264236, 2T0S264256, 2T0S264239, 1T0S260442, 1T0S260555, 1T0S260595, 1T0S260603, 1T0S260606, 1T0S260607, 1T0S260609, 1T0S260610, 1T0S260611, 1T0S260612, 1T0S260613, 1T0S260614, 1T0S260615, 1T0S260619, 1T0S260622, 1T0S260627, 1T0S260635, 1T0S260639, 1T0S260641, 1T0S260650, 1T0S260661, 1T0S260678, 1T0S260724, 1T0S260760, 1T0S260768, 1T0S260771, 1T0S260774, 1T0S260783, 2T0S262650, 2T0S262689, 2T0S262694, 2T0S262698, 2T0S262712, 2T0S263634, 2T0S263821, 2T0S263836, 2T0S266610, 2T0S266633, 2T0S264058, 2T0S264081, 8T0S226502, 8T0S229547, 8T0S229559, 8T0S229563, 8T0S229570, 8T0S229574, 8T0S229575, 8T0S229582, 8T0S229583, 8T0S229586, 8T0S229590, 8T0S229601, 8T0S233656, 8T0S233657, 2T0S264214, 0T0S251261, 0T0S251286, 0T0S251319, 0T0S251792, 0T0S251811, 0T0S251809, 0T0S251810, 9T0S236793, 0T0S251309, 2T0S263496, 2T0S263531, 0T0S248136, 0T0S248150, 0T0S248148, 0T0S248156, 1T0S260397, 1T0S260419, 1T0S260349, 1T0S260427, 1T0S260346, 1T0S260433, 1T0S260352, 1T0S260358, 1T0S260370, 1T0S260429, 1T0S260374, 1T0S260367, 1T0S260423, 1T0S260616, 1T0S260637, 1T0S260707, 1T0S260823, 1T0S260405, 1T0S260424, 1T0S260311.