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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 31 Results
510(K) Number: K842648
 
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DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN. 3 02/23/2017 DeRoyal Industries Inc
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 2 09/30/2024 DeRoyal Industries Inc
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit 2 10/16/2023 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
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hosp... 2 06/07/2023 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 Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors 2 08/31/2022 DeRoyal Industries Inc
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and iso... 2 04/06/2022 DeRoyal Industries Inc
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl al... 2 04/06/2022 DeRoyal Industries Inc
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom sur... 2 02/19/2021 DeRoyal Industries Inc
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