Recall Z-0145-2014 ยท FJL Resectoscope
Richard Wolf Medical Instruments Corp.
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426
| Date | Nov 4, 2013 (initiated Sep 18, 2013) |
| Status | Terminated |
| Reason | Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch. |
| Root cause | Process control |
| Action | The firm, Richard Wolf, sent an "Urgent: Medical Device Recall" letter dated September 16, 2013, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory of vaporization electrodes from lot 426111, contact Richard Wolf Medical Instrument Corporation at 800-323-9653 x 344 or ext 225 or ext. 380 to inform Richard Wolf Medical Instrument Corporation if the customer has or does not have any devices from this lot, return the affected devices with the return authorization provided by Richard Wolf Medical Instrument |
| Quantity | 78 cartons (234 units) |
| Distribution | Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES Richard Wolf Medical Instruments Corp., Mar 22, 2007 |