Recall Z-0145-2014
Richard Wolf Medical Instruments Corp. · initiated September 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: *** 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;
Reason for recall
Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
FDA-determined cause: Process control
Action taken
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 Corporation for credit, and complete and return the attached Recall Response form via fax to: 847-913-0924; email: dclark@richardwolfusa.com; or mailed to: Richard Wolf Medical Instrument Corporation, 353 Corporate Woods Parkway, Vernon Hills, IL 60061-3110. Customers who require urgent replacement of the affected devices can contact their customer service representative for replacement. If you have any questions, call 800-323-9653 x 344.
Details
- Recall number
- Z-0145-2014
- Initiated
- September 18, 2013
- Posted by FDA
- November 4, 2013
- Terminated
- April 24, 2017
- Product code
- FJL – Resectoscope
- 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.
- Recalling firm
- Richard Wolf Medical Instruments Corp., Vernon Hills, IL