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U.S. Department of Health and Human Services

Class 2 Device Recall YNHH SCOPE KIT

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  Class 2 Device Recall YNHH SCOPE KIT see related information
Date Initiated by Firm June 24, 2019
Create Date November 15, 2019
Recall Status1 Terminated 3 on July 24, 2020
Recall Number Z-0408-2020
Recall Event ID 83359
Product Classification Ear, nose, and throat surgical tray - Product Code OGR
Product YNHH SCOPE KIT
Kit Code: MNS10475
Code Information Lot # 2019060750 Exp 08/31/2020 Lot # 2019060450 Exp 08/31/2020 Lot # 2018110550 Exp 05/31/2020       
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact Lisa A. Carpenter
517-546-5400 Ext. 1156
Manufacturer Reason
for Recall		 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer.
FDA Determined
Cause 2		 Material/Component Contamination
Action 1. Please identify all inventory that you have within your possession. Remove the MAJOR Nasal Decongestant from the mini-grip bag and segregate it in a location where it cannot be accessed for use. 2. Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of this recall response, a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3. please forward a copy of this notice to any facilities to whom this product may have been further distributed. If you have any questions, please contact (517) 546-5400 Ext 1122.
Quantity in Commerce 644 Kits
Distribution CT, IL
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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