Reported Nov 18, 2015 · Terminated
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos:…
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?
9 of 9 products
| Model / number | Product as published |
|---|---|
89-4561.11 | DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B |
89-4562.12 | TOTAL HIP A & B |
89-3101.04 | PODIATRY TRAY |
89-7744.03 | KNEE SCOPE PACK |
89-8194.02 | KNEE PACK |
89-8439.01 | BEACH CHAIR PACK |
50-12160.17 | TOTAL JOINT |
50-12602.09 | BACK TRAY |
89-8381.01 | PACEMAKER PACK |
- Amount recalled
- 355 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
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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