Recall Z-2227-2023 ยท CAE Airway, Oropharyngeal, Anesthesiology
MEDLINE INDUSTRIES, LP - Northfield
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
| Date | Jul 21, 2023 (initiated Mar 28, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 | 9945 ea |
| Distribution | Worldwide distribution - US Nationwide and the country of Bermuda. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.