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DeRoyal Industries Inc recalls DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Recalled September 7, 2016 · FDA recall Z-2679-2016 · DeRoyal Industries
Hazard
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. · FDA Class II
Units
24 units
Sold at
Distributed in LA and TN.
Description
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.
Product
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →