Reported Mar 3, 2021 · Terminated
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 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?
- Open Heart Pack
- REF numbersa) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Lot Numbers: 50033361 exp 11/1/2021, 50404628 exp 12/1/2021, 50783200 exp 12/1/2021 c) 89-7483.09 2 Lot Numbers: 51021872 exp 12/1/2021, 51121460 exp 4/1/2022, 51284373 exp 4/30/2022, 51458898 exp 4/1/2022, 51701317 exp 7/1/2022 d) 89-7483.10 3 Lot Numbers: 51954402 exp 9/1/2022, 52183224 exp 9/1/2022, 52413069 exp 10/1/2022, 53117579 exp 10/1/2022, 53311005 exp 11/1/2022 - Amount recalled
- 1084 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.
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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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