Reported Sep 7, 2016 · Terminated
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
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?
- DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
- Lot codes and dates
- Lot Number 40004006
- Amount recalled
- 24 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
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
This product could cause temporary or reversible health problems — stop using it.
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