FDA-Device2023-07-12Class II
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
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
328 packs
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2088-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief