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
54310362exp. 01/01/202254366825exp. 01/01/2022
- Lot Numbers
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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