Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telesco

FDA device recall Z-0145-2014 · posted 2013-11-04 · Terminated

Recall details

Recalling firm

Richard Wolf Medical Instruments Corp.

Reason for recall

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

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.

Root cause

Process control

Status

Terminated

Product code

FJL

Quantity affected

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.

Date initiated

2013-09-18

Date posted

2013-11-04

Date terminated

2017-04-24

Location

Vernon Hills, IL

Related 510(k) clearances