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 PACEMAKER ICD PACK, REF 89-10216.03 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 PACEMAKER ICD PACK, REF 89-10216.06 Nov 3, 2022 FDA device enforcement
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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 ARTHOSCOPY PACK, REF 89-10240.03 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 CRANI PACK, REF 89-10242.02 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 CRANI PACK, REF 89-10242.04 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 HAND PACK, REF 89-10314.02 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 HAND PACK, REF 89-10314.03 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 PAIN TRAY, REF 89-10464.02 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 PAIN TRAY, REF 89-10464.03 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 CNRV PERIPHERAL VAS PACK, REF 89-10530.03 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 CNRV SPINAL PACK, REF 89-10532.03 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 CARDIAC LINEN PACK, REF 89-10543.02 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 CMC POSTERIOR SPINE PACK, REF 89-10570.01 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 DISC PACK, REF 89-10590.02 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 DISC PACK, REF 89-10605.02 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 ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01 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 GU PACK, REF 89-10665.02 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 GU PACK, REF 89-10665.03 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 NEURO PACK, REF 89-10682.02 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 LAMI/CRANI PACK, REF 89-10787.01