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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95428

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 13, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Spectrum Medical Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-0224-2025
Initiated
March 13, 2023
Classification
Class II
Status
Completed
Recalling firm
Spectrum Medical Ltd.
Quantity
172 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.