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Terminated

Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

FDA Recall Z-1075-2017 · Posted None

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeEQL
Date Initiated2016-12-12
Date Terminated2019-03-22
Product Quantity2,056 (1,545 (US) and 511 (OUS))

Reason for Recall

Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.

Firm Action

The firm, Pentax Medical, sent an "U.S. URGENT FIELD CORRECTION" letter and a Return Response form dated December 12, 2016 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all users read and carefully follow the revised IFU in order to properly operate and reprocess the affected product; contact your PENTAX Medical sales representative to arrange for training regarding the new procedures, and complete and return the FIELD CORRECTION RESPONSE FORM via fax to: PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or email a pdf copy to [email protected] even if you no longer possess the product. If you have any questions regarding this action, please feel free to contact us at: 800-431-5880 (8:30 AM-5:00 PM, Monday-Friday, EST) or email: [email protected].

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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