Medline Laryngeal Masks recalled due to potential cuff disconnection
Medline Industries is recalling approximately 8,990 cases of Standard PVC Laryngeal Masks distributed nationwide because the mask cuff may disconnect from the breathing tube.
What this means for you
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 FDA Class II recall involves a functional defect in a medical airway device where the cuff may disconnect from the breathing tube. While no injuries are reported in the source text and the hazard is currently theoretical, such disconnection during airway use poses inherent risk to patient safety.
Plain-English summary
Medline Industries is recalling approximately 8,990 cases of Standard PVC Laryngeal Masks distributed nationwide. The masks are single-use airway devices delivered as 1 device per pouch in boxes of 5 pouches.
The cuff of the laryngeal mask may disconnect from the device's breathing tube. This disconnection could compromise the mask's function during airway management.
Healthcare providers and facilities should verify their inventory using the item numbers and lot numbers provided in the FDA recall notice and identify affected products from the specified lots.
The recalled product
- Product
- Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- cuff-disconnection
- airway-compromise
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)
- Medline Item Number and Lot(s): 1) DYND290010
- Lot 63521050001 (UDI: 10193489036688) 2) DYND290015
- Lot 63521050001 (UDI: 10193489036695) 3) DYND290020
- Lots 63521050001
- 63521110001
- and 63521100002 (UDI: 10193489036701) 4) DYND290025
- and 63521100002 (UDI: 10193489036718) 5) DYND290030
- 63521100002
- 63521050002
- and 63521110001 (UDI: 10193489036725) 6) DYND290040
- and 63521110001 (UDI: 10193489036732) 7) DYND290050
- and 63521100002 (UDI: 10193489036749)
Distribution
Distributed nationwide across the United States.
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