FDA-Device2023-06-14Class II
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
DeRoyal Industries Inc
Hazard
The custom procedure packs contain light handle covers that have been recalled by another firm.
Sold states
US Nationwide distribution in the state of VA.
Affected count
23 cases (52 packs)
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2023Don't want to check this manually?
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