Reported Nov 18, 2015 · Terminated
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630,…
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?
4 of 4 products
| Model / number | Product as published |
|---|---|
863 | Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or |
| — | Lot No. 2016-08DC: TOTAL JOINT PACK A&B |
89-5720.04 | PACEMAKER PACK |
89-6717.03 | — |
- Lot codes and dates
REF 89-5720.04Lot Number 38322988REF 89-6717.03
- Lot Numbers38323059 and 38342436
- Amount recalled
- N/A
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.
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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