Recall Z-0145-2014— Richard Wolf Medical Instruments Corp.

Name: FDA recall Z-0145-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-18

Class II · Terminated

Class II FDA medical device recall by Richard Wolf Medical Instruments Corp., initiated 2013-09-18, terminated 2017-04-24. It names one FDA 510(k) clearance: K062720. Product: 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 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.. Reason: Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch..

Recalling firm: Richard Wolf Medical Instruments Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-09-18
Terminated: 2017-04-24
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODESRichard Wolf Medical Instruments Corp.·cleared 2007-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.

Reason for recall

Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.