FDAFDA · Food and drugs·Recall number Z-0145-2014
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.
Published November 13, 2013 · Recall initiated: September 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Richard Wolf Medical Instruments Corp.
- Distributor
- Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.
- Lot
- *** 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;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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