FDAClass IINovember 13, 2013

Individual units labeled in recall

Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for…

Why was Individual units labeled in recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

*** 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;

Product
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for…
Recalling firm
Richard Wolf Medical Instruments Corp.
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.
Recall date
November 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls