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Recall Observatory FDA recall evidence

Device product

Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

Z-0224-2025

March 13, 2023

Class II

Product summary

Firm
Spectrum Medical Ltd.
Event
Event 95428
Status
Completed
Classification
Class II
Quantity
172 units
Official record key
device-enforcement:Z-0224-2025

Official wording

Reason: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

Code information: UDI/DI 05060434420770: Serial Numbers: a) AU6004040, AU6004041, AU6004042, AU6004043, AU6004044, AU6004046, AU6004050, AU6004051, AU6004052, AU6004053, AU6004054, AU6004056, AU6004057, AU6004058, AU6004060, AU6004061, AU6004062, AU6004063, AU6004064, AU6004065, AU6004066, AU6004069, AU6004070, AU6004071, AU6004072, AU6004073, AU6004074, AU6004075, AU6004136, AU6004137, AU6004138, AU6004139, AU6004140, AU6004141, AU6004142, AU6004143, AU6004144, AU6004145, AU6004146, AU6004147, AU6004148, AU6004159, AU6004160, AU6004161, AU6004162, AU6004167, AU6004168, AU6004169, AU6004170, AU6004171, AU6004172, AU6004173, AU6004174, AU6004175, AU6004176, AU6004177, AU6004178, AU6004179, AU6004180, AU6004181, AU6004182, AU6004183, AU6004184, AU6004185, AU6004186, AU6004187, AU6004188, AU6004195, AU6004197, AU6004198, AU6004200, AU6004201, AU6004202, AU6004203, AU6004204, AU6004205, AU6004207, AU6004332, AU6004333, AU6004348, AU6004349, AU6004350, AU6004352, AU6004353, AU6004354, AU6004532, AU6004577, AU6004578, AU6004579, AU6004580, AU6004587, AU6004588, AU6004590, AU6004591, AU6004603, AU6004604, AU6004605, AU6004606, AU6004607, AU6004609, AU6004610, AU6004613, AU6004731, AU6004771, AU6004773, AU6004776, AU6004777, AU6004778, AU6004779, AU6004781, AU6004782, AU6004919, AU6004920, AU6004921, AU6004922, AU6004923, AU6004924, AU6004925, AU6004926, AU6004927, AU6004929, AU6004930, AU6004955, AU6004957, AU6004958, AU6004960, AU6004963, AU6004966, AU6004968, AU6004970, AU6004971, AU6004972, AU6005010, AU6005021, AU6005022, AU6005023, AU6005024, AU6005025, AU6005026, AU6005027, AU6005028, AU6005029, AU6005030, AU6005037, AU6005038, AU6005039, AU6005040, AU6005041, AU6005042, AU6005057, AU6005065, AU6005109, AU6005110, AU6005118, AU6005124, AU6005125, AU6005355, AU6006351; Serial Numbers: b) AU8001273, AU8001275, AU8001346, AU8001347, AU8001348, AU8001359, AU8001360, AU8001366, AU8001403, AU8001406, AU8001407, AU8001446, AU8001447, AU8001449

Distribution pattern: US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.