FDA-Device2016-09-07Class II
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
DeRoyal Industries Inc
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.
Sold states
Distributed in LA and TN.
Affected count
26 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2678-2016Don't want to check this manually?
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