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Terminated

E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

FDA Recall Z-1957-2019 · Posted 2019-06-13

Recall StatusTerminated
Product CodeHIH
Date Initiated2019-05-23
Date Terminated2020-08-04
Product Quantity5 boxes (5 electrodes each)

Reason for Recall

E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

Firm Action

Richard Wolf Medical Instruments, Corp. notified customers on 05/23/2019 via "Urgent Safety Information: Recall" letter. Instructions included to examine distribution reports and stock immediately to determine if any affected devices are on hand, quarantine any affected devices, advise customers of the recall if affected devices were further distributed, and scrap all affected devices on site. Customers were also instructed to complete and return the Answer form provided with the notification letter. An updated "Urgent Safety Information: Recall" letter was sent via email on 06/07/2019 to customers. The letter contained an update to include the hazard and risk. Instructions to customers remained the same as in the original letter.

Root Cause

Under Investigation by firm

Distribution Pattern

US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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