FDA-Device2014-08-06Class II

DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.

DeRoyal Industries Inc
Hazard

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

Sold states
Distributed in the states of MI, GA, OH, IL, MO, and IN.
Affected count
128 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2124-2014

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