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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 26 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 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 Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl al... 2 04/06/2022 DeRoyal Industries Inc
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and iso... 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
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Cus... 2 02/19/2021 DeRoyal Industries Inc
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
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient ... 2 02/19/2020 Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular ... 2 02/19/2020 Deroyal Industries, Inc. Lafollette
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