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2008T BlueStar Hemodialysis Machine recallZ-1869-2024 · Fresenius Medical Care Holdings, Inc. · initiated Apr 17, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-1869-2024
Status
Open, Classified
Initiated by the company
Apr 17, 2024
Posted by the FDA
May 17, 2024
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
334 units
Product code
KDI
FDA submissions
K173972, K222952, K231125
Distribution
US Nationwide distribution.

Product description

2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI: 00840861102105; Serial Numbers: 3T0S274210, 1T0S260183, 1T0S260455, 1T0S260456, 1T0S260485, 1T0S260273, 1T0S260283, 1T0S260490, 1T0S260158, 1T0S260182, 1T0S260266, 3T0S269011, 3T0S273223, 3T0S274216, 3T0S274225, 3T0S274678, 3T0S274680, 1T0S260281, 2T0S268008, 2T0S268016, 2T0S264775, 2T0S268009, 2T0S268013, 2T0S268014, 2T0S268015, 3T0S269021, 3T0S269026, 3T0S274215, 3T0S274222, 3T0S274231, 3T0S274234, 1T0S260154, 1T0S260481, 1T0S260543, 1T0S260550, 1T0S260552, 3T0S274213, 3T0S274230, 1T0S260242, 1T0S260250, 1T0S260510, 1T0S260514, 2T0S267901, 2T0S267905, 2T0S267906, 2T0S267911, 1T0S260541, 1T0S260546, 2T0S264780, 3T0S274233, 3T0S274685, 3T0S274691, 3T0S274697, 1T0S260159, 1T0S260164, 1T0S260172, 1T0S260212, 1T0S260216, 1T0S260221, 1T0S260269, 1T0S260270, 1T0S260276, 1T0S260292, 1T0S260295, 1T0S260528, 3T0S273221, 3T0S274217, 3T0S274218, 3T0S274219, 3T0S274220, 3T0S274223, 3T0S274226, 3T0S274227, 3T0S274228, 3T0S274232, 3T0S274682, 3T0S274684, 3T0S274690, 3T0S274692, 3T0S274693, 3T0S274698, 1T0S260150, 1T0S260174, 1T0S260192, 1T0S260554, 1T0S260534, 3T0S274214, 3T0S274688, 1T0S260286, 2T0S264786, 3T0S274679, 3T0S274681, 3T0S274683, 3T0S274686, 3T0S274694, 3T0S274695, 3T0S274699, 3T0S274700, 1T0S260544, 1T0S260268, 1T0S260294, 3T0S269020, 3T0S269030, 3T0S269031, 1T0S260227, 2T0S267900, 2T0S267904, 1T0S260284, 1T0S260457, 1T0S260548, 3T0S269013, 3T0S269015, 3T0S269028, 3T0S271557, 3T0S271562, 3T0S271563, 3T0S271570, 3T0S271571, 3T0S271573, 3T0S271574, 3T0S271575, 3T0S271576, 3T0S269033, 3T0S269035, 3T0S271561, 3T0S271566, 3T0S271568, 3T0S273244, 1T0S260493, 1T0S260501, 1T0S260506, 1T0S260515, 1T0S260526, 1T0S260279, 1T0S260155, 1T0S260156, 1T0S260166, 1T0S260167, 1T0S260185, 1T0S260188, 1T0S260200, 3T0S269014, 3T0S269016, 3T0S269022, 2T0S264805, 2T0S264776, 2T0S264778, 2T0S264794, 2T0S264818, 2T0S264822, 2T0S264787, 2T0S264792, 3T0S269017, 3T0S269018, 3T0S269019, 3T0S271558, 3T0S271560, 3T0S271564, 3T0S271565, 3T0S271572, 1T0S256406, 2T0S267910, 3T0S273219, 3T0S273232, 3T0S274221, 1T0S260151, 1T0S260178, 1T0S260152, 1T0S260278, 1T0S260288, 1T0S260488, 1T0S260533, 1T0S260249, 1T0S260259, 1T0S260262, 1T0S260198, 1T0S260291, 2T0S268012, 1T0S260173, 3T0S274211, 3T0S274224, 2T0S268011, 3T0S273220, 3T0S273222, 3T0S273224, 3T0S273225, 3T0S273226, 3T0S273227, 3T0S273228, 3T0S273229, 3T0S273230, 3T0S273233, 3T0S273234, 3T0S273235, 3T0S273236, 3T0S273237, 3T0S273238, 3T0S273239, 3T0S273240, 3T0S273241, 3T0S273242, 3T0S273243, 1T0S260267, 1T0S260275, 3T0S269012, 3T0S269023, 3T0S269024, 3T0S269025, 3T0S269027, 3T0S269029, 3T0S269032, 3T0S269034, 1T0S260204, 1T0S260460, 1T0S260482, 1T0S260513, 1T0S260516, 1T0S260527, 1T0S260540, 1T0S260545, 2T0S267903, 2T0S264781, 3T0S271559, 3T0S271567, 3T0S271569, 1T0S260290, 1T0S260175, 1T0S260282, 1T0S260508, 1T0S260566, 1T0S260285, 2T0S264783, 2T0S264814, 1T0S260157, 1T0S260161, 1T0S260162, 1T0S260163, 1T0S260165, 1T0S260169, 1T0S260176, 1T0S260177, 1T0S260179, 1T0S260187, 1T0S260189, 1T0S260191, 1T0S260193, 1T0S260195, 1T0S260196, 1T0S260197, 1T0S260199, 1T0S260201, 1T0S260202, 1T0S260203, 1T0S260207, 1T0S260208, 1T0S260209, 1T0S260210, 1T0S260211, 1T0S260213, 1T0S260214, 1T0S260215, 1T0S260217, 1T0S260218, 1T0S260219, 1T0S260220, 1T0S260222, 1T0S260223, 1T0S260224, 1T0S260225, 1T0S260228, 1T0S260229, 1T0S260230, 1T0S260231, 1T0S260232, 1T0S260233, 1T0S260235, 1T0S260236, 1T0S260237, 1T0S260239, 1T0S260243, 1T0S260245, 1T0S260247, 1T0S260251, 1T0S260253, 1T0S260255, 1T0S260256, 1T0S260257, 1T0S260258, 1T0S260260, 1T0S260272, 1T0S260453, 1T0S260458, 1T0S260459, 1T0S260483, 1T0S260500, 1T0S260502, 1T0S260507, 1T0S260519, 1T0S260523, 1T0S260531, 1T0S260542, 1T0S260549, 1T0S260553, 1T0S260565, 2T0S264774, 2T0S264777, 2T0S264779, 2T0S264782, 2T0S264784, 2T0S264788, 2T0S264791, 2T0S264793, 2T0S264796, 2T0S264797, 2T0S264800, 2T0S264801, 2T0S264803, 2T0S264804, 2T0S264807, 2T0S264811, 2T0S264819, 2T0S264821, 2T0S268010, 1T0S260194, 1T0S260238, 1T0S260293, 1T0S260461, 2T0S264802, 3T0S274212, 2T0S267899, 2T0S267902, 2T0S267907, 2T0S267908, 2T0S267909.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K173972, K222952, K231125 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94463).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page