Z-2227-2023 Class II Ongoing
FDA device recall Z-2227-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on March 28, 2023 and is designated Class II. 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 e… The recall status is ongoing. Affected quantity: 9945 ea.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- March 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9945 ea
Product Description
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
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 Pattern
Worldwide distribution - US Nationwide and the country of Bermuda.
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)