FDA-Device2021-06-16Class I
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
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
66 packs
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1833-2021Don't want to check this manually?
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