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    AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NTI·March 9, 2007

    AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NTI·March 9, 2007

    AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 12, 2007

    Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8); 12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3); 13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R); 14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8); 15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33); 16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17); 17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18); 18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24); 19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12); 20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7); 21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6); 22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6); 23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1); 24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4); 25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4); 26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6); 27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4); 28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12); 29. PERFUSION M337112Q 1/B (Model M337112Q); 30. PERFUSION M344130B 1/B (Model M344130B); 31. PERFUSION M392419C 1/B (Model M392419C); 32. PERFUSION M394213B 1/B (Model M394213B); 33. PERFUSION M394213C 1/B (Model M394213C); 34. PERFUSION M490124D 1/B (Model M490124D); 35. PERFUSION M491335A 1/B (Model M491335A); 36. PERFUSION M499709E 1/B (Model M499709E); 37. PERFUSION M960164F 1/B (Model M960164F); 38. PERFUSION M960165E 1/B (Model M960165E); 39. PERFUSION M960169E 1/B (Model M960169E); 40. PERFUSION M960462C 1/B (Model M960462C); 41. PERFUSION M960462D 1/B (Model M960462D); 42. PERFUSION M960463D 1/B (Model M960463D); 43. PERFUSION M960466D 1/B (Model M960466D); 44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3); 45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12); 46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5); 47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9); 48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·October 12, 2021

    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

    FDA Recall
    Open, Classified ·Brasseler USA I Lp·Product code EJL·January 11, 2024

    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

    FDA Recall
    Terminated ·Brasseler USA I Lp·Product code GFF·October 18, 2019

    Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

    FDA Recall
    Terminated ·Brasseler USA I Lp·Product code HTY·December 11, 2019

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Recall
    Terminated ·NEUSOFT MEDICAL SYSTEMS IMP &·Product code JAK·January 9, 2019

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022