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Recall Observatory FDA recall evidence

Device product

Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

Z-2678-2016

August 11, 2016

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 74927
Status
Terminated
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-2678-2016

Official wording

Reason: 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.

Code information: Lot Number 40259236

Distribution pattern: Distributed in LA and TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.