Reported Nov 13, 2013 · Terminated
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm…
Richard Wolf Medical Instruments Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Richard Wolf Medical Instruments Corp. · 353 Corporate Woods Pkwy · Vernon Hills, IL · 60061-3110
Is this the product you have?
18 of 18 products
| # | Product as published |
|---|---|
| 1 | Individual units labeled in part: REF: 4630022 |
| 2 | for S(a)line resectoscopes |
| 3 | Vaporization electrode, sterite |
| 4 | 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr. |
| 5 | LOT 426111 |
| 6 | 2011/06 |
| 7 | 2016/06 |
| 8 | STERILE |
| 9 | RICHARD WOLF |
| 10 | Cartons of 3 units labeled in part: REF 46300223 |
| 11 | Vaporization electrode, sterile |
| 12 | 4mm telescope 30/25/12 |
| 13 | only for continuous irrigation sheath 24,5 Fr. |
| 14 | Lot 426111 |
| 15 | 2011/06 |
| 16 | 2016/06 |
| 17 | STERILE |
| 18 | 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. |
- Lot codes and dates
- *** Individual Units ***
- Product Code4630022 (single)
- Lot426111
- Expiration Date2016/06; *** Cartons ***
- Product Code46300223 (box of 3)
- Lot426111
- Expiration Date2016/06
- Amount recalled
- 78 cartons (234 units)
Where it was sold
Why it was recalled
Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
This product could cause temporary or reversible health problems — stop using it.
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