FDA-Device2021-06-16Class I

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

DeRoyal Industries Inc
Hazard

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

Sold states
US Nationwide distribution to the states of MS, VA, LA, and NY.
Affected count
60 trays
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal Angio Cath Removal Tray, REF 89-9936.02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1834-2021

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