Reported Oct 30, 2024 · Completed
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial…
Spectrum Medical Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectrum Medical Ltd. · Harrier 4, Meteor Business Park · Gloucester, N/A · N/A
Is this the product you have?
- Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing
- Catalog Numbers
a) 51-000013-00b) 51-000008-00
- Lot codes and dates
- UDI/DI 05060434420770Serial
- Numbers
158 of 158 codes
a) AU6004040AU6004041AU6004042AU6004043AU6004044AU6004046AU6004050AU6004051AU6004052AU6004053AU6004054AU6004056AU6004057AU6004058AU6004060AU6004061AU6004062AU6004063AU6004064AU6004065AU6004066AU6004069AU6004070AU6004071AU6004072AU6004073AU6004074AU6004075AU6004136AU6004137AU6004138AU6004139AU6004140AU6004141AU6004142AU6004143AU6004144AU6004145AU6004146AU6004147AU6004148AU6004159AU6004160AU6004161AU6004162AU6004167AU6004168AU6004169AU6004170AU6004171AU6004172AU6004173AU6004174AU6004175AU6004176AU6004177AU6004178AU6004179AU6004180AU6004181
- Serial Numbers
b) AU8001273AU8001275AU8001346AU8001347AU8001348AU8001359AU8001360AU8001366AU8001403AU8001406AU8001407AU8001446AU8001447AU8001449
- Amount recalled
- 172 units
Where it was sold
Why it was recalled
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
This product could cause temporary or reversible health problems — stop using it.
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