Z-2227-2023Class II

DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs

Name: Z-2227-2023 DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-03-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-03-28 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs on 2023-03-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2227-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-28
Posted: 2023-07-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2227-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2227-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)