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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Laryngeal Mask Airway Pack

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  Class 2 Device Recall Medline Laryngeal Mask Airway Pack see related information
Date Initiated by Firm March 28, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2227-2023
Recall Event ID 92572
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Code Information All Lots for series since product launch; Model Number (Unique Device Identifier) -DYND300010P (Each level packaging: 10193489010671; Case level packaging: 20193489010678); DYND300015P (Each level packaging: 10193489010688; Case level packaging: 20193489010685); DYND300020P (Each level packaging: 10193489010695; Case level packaging: 20193489010692); DYND300025P (Each level packaging: 10193489010701 Case level packaging: 20193489010708); DYND300030P (Each level packaging: 10193489010718; Case level packaging: 20193489010715); DYND300040P (Each level packaging: 10193489010725; Case level packaging: 20193489010722); DYND300050P (Each level packaging: 10193489010732; Case level packaging: 20193489010739)
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		 The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.
FDA Determined
Cause 2		 Labeling Change Control
Action The consignee recall notification was sent out via first class mail and email on 03/28/2023. The letter instructs the consignee to over-label the Flexible Laryngeal Mask Airway Packs stating to Check the Expiration date of Lubricating Jelly MDS032280 and do not use if Expired . No product is to be returned back to Medline Industries, LP.
Quantity in Commerce 9945 ea
Distribution Worldwide distribution - US Nationwide and the country of Bermuda.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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