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FDA (Device enforcement)Recalled 2023-03-28class ii

MEDLINE INDUSTRIES, LP - Northfield: DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs

Hazard

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.

Details from the source

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. Distribution: Worldwide distribution - US Nationwide and the country of Bermuda. Quantity: 9945 ea Lot/code info: 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)

UPC codes

10193489010671, 20193489010678, 10193489010688, 20193489010685, 10193489010695, 20193489010692, 10193489010701, 20193489010708, 10193489010718, 20193489010715, 10193489010725, 20193489010722, 10193489010732, 20193489010739

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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