Medline convenience kits containing semi-rigid suction recall
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number…
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) DYKE1350D: UDI/DI case 40193489339797, UDI.DI each 10193489339796; Lot Numbers: 24CBG448, 24EBF166; b) DYKE1514B: UDI/DI case 40193489797832, UDI.DI each 10193489797831; Lot Numbers: 24CBR722, 24FBA408
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1616 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)