FDAFDA · Food and drugs·Recall number Z-3109-2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF, Pack Number DYNJ908429; f) MASTOPEXY-CANNOVA, Pack Number DYNJ909948
Published September 18, 2024 · Recall initiated: June 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot
- a) DYKE1456D: UDI/DI case 40195327639939, UDI/DI each 10195327639938, Lot Numbers: 24CBK289, 24BBK989; b) DYNJ908099B: UDI/DI case 40195327507085, UDI/DI each 10195327507084, Lot Numbers: 24DBI371, 24BBA188; c) DYNJ908101B: UDI/DI case 40195327507092, UDI/DI each 10195327507091, Lot Numbers: 24CBE408, 24BBA260, 24ABB112; d) DYNJ908105B: UDI/DI case 40195327507122, UDI/DI each 10195327507121, Lot Numbers: 24ABV362; e) DYNJ908429: UDI/DI case 40195327078820, UDI/DI each 10195327078829, Lot Numbers: 24CBB310, 23LBV007; f) DYNJ909948: UDI/DI case 40195327512911, UDI/DI each 10195327512910, Lot Numbers: 24DBD609
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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