Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal FOOT PACK, REF 89-9252.08 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal NEURO PACK, REF 89-9253.07 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal NEURO PACK, REF 89-9253.09 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal BIOPSY PACK, REF 89-9270.04 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal BIOPSY PACK, REF 89-9270.05 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal TOTAL KNEE PACK, REF 89-9300.08 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal TOTAL HIP PACK, REF 89-9301.07 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal MYELOGRAM PACK, REF 89-9304.05 Nov 3, 2022 FDA device enforcement
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal MYELOGRAM PACK, REF 89-9304.06 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal SHOULDER PACK, REF 89-9449.12 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal SHOULDER PACK, REF 89-9449.13 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal SHOULDER KIT, REF 89-9497.08 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal SHOULDER KIT, REF 89-9497.10 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal TOTAL HIP KIT, REF 89-9498.08 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal TOTAL HIP KIT, REF 89-9498.10 Nov 3, 2022 FDA device enforcement
XXX
Class II Reported ongoing
Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minne...
Official source for DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11