Reported Jun 16, 2021 · Terminated

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

DeRoyal Industries Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703

Is this the product you have?

  • DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Lot codes and dates
  • Lot Numbers
    • 54310362
    • exp. 01/01/2022
    • 54366825
    • exp. 01/01/2022
Amount recalled
66 packs

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 21, 2023 · Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.