DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
This recall is currently active, issued July 21, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 28, 2023
- Posted
- July 21, 2023
- Recall Number
- Z-2227-2023
- Quantity
- 9945 ea
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
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)
Root Cause
Labeling Change Control
Action Taken
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.