Reported Mar 3, 2021 · Terminated
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Heart Pack
- REF numbersa) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades
- Lot codes and dates
a) 89-9194.07Lot Numbers47782581 exp 5/1/2021 b) 89-9194.09
- Lot Numbers
50224694 exp 9/1/202350326092 exp 9/1/202350582301 exp 9/1/202350795307 exp 11/1/202351008862 exp 11/1/202351153103 exp 11/1/2023 c) 89-9194-10
- Lot Numbers
51434221 exp 11/1/202351881522 exp 11/1/2023 d) 89-9194-11
- Lot Numbers
52175785 exp 8/1/202252849153 exp 11/1/202353220664 exp 2/1/202553327306 exp 2/1/202553409521 exp 9/1/202353565355 exp 12/1/2024
- Amount recalled
- 776 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
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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