FDAClass IISeptember 18, 2024

Medline convenience kits containing semi-rigid suction recall

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR…

Why was Medline convenience kits containing semi-rigid suction recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

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

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
407 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Recall date
September 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls