device · product 1 of 1
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.
- Recall number
- Z-0145-2014
- Initiated
- September 18, 2013
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Quantity
- 78 cartons (234 units)
App-derived interpretation
Unknown
Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
Code information
*** Individual Units *** Product Code: 4630022 (single); Lot: 426111; Expiration Date: 2016/06; *** Cartons *** Product Code: 46300223 (box of 3); Lot: 426111; Expiration Date: 2016/06;
Distribution pattern
Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.