FDAClass IIApril 20, 2022

Medline Standard PVC Laryngeal Masks recall

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

Why was Medline Standard PVC Laryngeal Masks recalled?

The mask cuff may disconnect from the device's breathing tube.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718) 5) DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725) 6) DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732) 7) DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749)

Product
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
8990 cases
Distribution
US Nationwide distribution.
Recall date
April 20, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls