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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax Rigid Laryngostroboscopes

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  Class 2 Device Recall Pentax Rigid Laryngostroboscopes see related information
Date Initiated by Firm December 12, 2016
Create Date January 23, 2017
Recall Status1 Terminated 3 on March 22, 2019
Recall Number Z-1075-2017
Recall Event ID 76089
Product Classification Laryngostroboscope - Product Code EQL
Product 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.
Code Information Model #'s 9106 and 9108
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact
800-431-5880
Manufacturer Reason
for Recall		 Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
FDA Determined
Cause 2		 Labeling design
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 customeradvisories@pentaxmedical.com 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: customeradvisories@pentaxmedical.com.
Quantity in Commerce 2,056 (1,545 (US) and 511 (OUS))
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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