Reported Feb 14, 2018 · Terminated
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB)…
Medtronic Perfusion Systems
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: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
- Lot codes and dates
16 of 16 products
Products covered by this recall Model / number Product as published 20885074191038REF 2815R1, UPN/ , Lot/Serial Numbers: 210937492, 213151103, 213671744 00613994268174REF 2D25R6, UPN/ , Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603, 210478517, 210591995, 210767149, 211011818, 211210404, 211243436, 211542842, 211761616 20643169876648REF 9M68R, UPN/ , Lot/Serial Numbers: 212067087, 212796361 00643169845121REF BB4B15R13, UPN/ , Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883, 212796215, 213248430, 213583108 00763000025878REF BB4B15R14, UPN/ , Lot/Serial Numbers: 213801240, 213868837 00643169845077REF BB9L72R, UPN/ , Lot/Serial Numbers: 211715103 00643169872127REF BB9L72R1, UPN/ , Lot/Serial Numbers: 212020797, 212174623, 212193001, 212301586, 212355584, 212428238, 212626142, 212884370, 213001157, 213248459, 213631247, 213672934, 213802501, 214072742, 214093025 00643169741591REF CB1Z87R11, UPN/ , Lot/Serial Numbers: 211755326 00643169735989REF CB4L56R24, UPN/ , Lot/Serial Numbers: 211654744, 211654745, 211800954 00643169906181REF CB4L56R26, UPN/ , Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166, 213358174, 213573495, 213623995, 214053395 20613994490760REF CB5S68R3, UPN/ , Lot/Serial Numbers: 210937507 00643169471986REF CB7X82R4, UPN/ , Lot/Serial Numbers: 211050766, 211320749 00643169789517REF CB7X82R5, UPN/ , Lot/Serial Numbers: 211423503, 211443209, 211443210, 211885323, 211991293, 212154744, 212235237, 212274655, 212428312, 212473311, 212671632, 212962650, 213126447, 213292357, 213377926, 213445426, 213494394, 213494396, 213672914, 213906498, 214043035, 214093030 00643169510432REF HY6Y19R5, UPN/ , Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742, 211846417, 212235012, 212545229, 212835348 00643169661295REF HY8M65R2, UPN/ , Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066, 212355669, 213001001, 213719738 00643169715097REF TL8W39R6, UPN/ , Lot/Serial Numbers: 210731697, 210838201, 210937704 - Amount recalled
- 2914 units
Where it was sold
Why it was recalled
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
This product could cause temporary or reversible health problems — stop using it.
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