FDA recall Z-2227-2023

Product

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

Worldwide distribution - US Nationwide and the country of Bermuda.

Key facts

Status

Ongoing

Initiation date

2023-03-28

Report date

2023-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2023