E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted int
FDA device recall Z-1957-2019 · posted 2019-06-13 · Terminated
Recall details
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HIH
- Quantity affected
- 5 boxes (5 electrodes each)
- Distribution
- US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.
- Date initiated
- 2019-05-23
- Date posted
- 2019-06-13
- Date terminated
- 2020-08-04
- Location
- Vernon Hills, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES (K980302) | Richard Wolf Medical Instruments Corp. | 1998-07-20 |