—#148840

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: Lot Number 40259236

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Distributed in LA and TN.

Timeline

Recall initiated: 2016-08-11
Posted by FDA: 2016-08-26
Terminated: 2017-06-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.