DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
FDA device recall Z-2227-2023 · posted 2023-07-21 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- CAE
- Quantity affected
- 9945 ea
- Distribution
- Worldwide distribution - US Nationwide and the country of Bermuda.
- Date initiated
- 2023-03-28
- Date posted
- 2023-07-21
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.