Flexible Laryngeal Mask Airway Packs Lack Required Expiration Date Labels
Medline Industries is recalling 9,945 DYND3000xxP Series laryngeal mask airway packs because the case and packet labels are missing expiration dates. Without this information, users cannot determine product validity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II labeling defect on a high-risk sterile medical device. Missing expiration dates on laryngeal mask airways create a risk-of-harm scenario through potential use of expired equipment without means of detection. No illnesses or injuries are currently reported, consistent with the High severity criterion.
Plain-English summary
Medline Industries is recalling 9,945 units of DYND3000xxP Series Flexible Laryngeal Mask Airway Packs due to a labeling defect. The case and packet labels do not display expiration dates, preventing users from determining whether the devices remain sterile and safe for clinical use.
Laryngeal mask airways are medical devices used in airway management. These devices must maintain sterility to ensure patient safety. While the lubricating jelly supplied with the product carries an expiration date on its label, the absence of expiration information on the mask packaging creates uncertainty about product shelf life and sterility assurance.
The affected product was distributed nationwide in the United States and to Bermuda. All lots of the DYND3000xxP series since the product's launch are included in this recall. Healthcare facilities and medical practitioners using these devices should check their inventory and contact Medline Industries for guidance on affected units.
The recalled product
- Product
- DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 9,945
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- All Lots for series since product launch
- Case level packaging: 20193489010678)
- DYND300015P (Each level packaging: 10193489010688
- Case level packaging: 20193489010685)
- DYND300020P (Each level packaging: 10193489010695
- Case level packaging: 20193489010692)
- 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)
Distribution
Distributed nationwide across the United States.
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