FDAClass IIAugust 2, 2023

DYND3000xxP Series - Flexible Laryngeal Mask Airway recall

DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs

Why was DYND3000xxP Series - Flexible Laryngeal Mask Airway recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
9945 ea
Distribution
Worldwide distribution - US Nationwide and the country of Bermuda.
Recall date
August 2, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls