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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 29 Results
510(K) Number: K842648
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CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-... 2 02/19/2021 DeRoyal Industries Inc
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC... 2 07/03/2023 DeRoyal Industries Inc
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, ST... 2 02/16/2018 DeRoyal Industries Inc
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O, 2 08/26/2016 DeRoyal Industries Inc
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and iso... 2 04/06/2022 DeRoyal Industries Inc
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit 2 10/16/2023 DeRoyal Industries Inc
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN. 3 02/23/2017 DeRoyal Industries Inc
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 2 01/09/2023 DeRoyal Industries Inc
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 1 06/10/2021 DeRoyal Industries Inc
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set 1 09/29/2021 Deroyal Industries, Inc. Lafollette