FDA-Device2023-07-12Class II
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
DeRoyal Industries Inc
Hazard
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Sold states
US Nationwide distribution.
Affected count
306 packs
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2090-2023Don't want to check this manually?
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