Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Check against the official notice below — it lists the full affected range.
Medline Industries is recalling Medline Standard PVC Laryngeal Masks distributed nationwide in the United States. The masks, which come one device per pouch with five pouches per box, may have a defect where the mask cuff disconnects from the device's breathing tube. A total of 8,990 cases are affected across multiple item numbers (DYND290010, DYND290015, DYND290020, DYND290025, DYND290030, DYND290040, and DYND290050) and various lot numbers.
The recall notice does not specify a remedy for consumers who have these products.
Written by software from the official notice below. Not reviewed by a lawyer.
The mask cuff may disconnect from the device's breathing tube.
Reason for recall: The mask cuff may disconnect from the device's breathing tube. Distribution: US Nationwide distribution. Quantity: 8990 cases Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.