FDAClass IISeptember 18, 2024

Medline convenience kits containing semi-rigid suction recall

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY…

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) CDS981509C: UDI/DI case 40195327071173, UDI/DI each 10195327071172, Lot Numbers: 24ABS277; b) CDS981512J: UDI/DI case 4019532759782610195327597825, Lot Numbers: 24BBP412; c) CDS981515D: UDI/DI case 4019532707196810195327071967, Lot Numbers: 23KDC374, 24CDB523, 24EDA579; d) DYNJ900709C: UDI/DI case 4019348995099210193489950991, Lot Numbers: 23LBU953; e) DYNJ900709D: UDI/DI case 4019532763531310195327635312, Lot Numbers: 24CBQ684; f) DYNJ900723C: UDI/DI case 4019348995162310193489951622, Lot Numbers: 24ABL637; g) DYNJ900723D: UDI/DI case 4019532763534410195327635343, Lot Numbers: 24CBG030, 24CBO759, 24EBJ696; h) DYNJ908098A: UDI/DI case 4019532750725210195327507251, Lot Numbers: 24ABY035; i) DYNJ908428: UDI/DI case 4019532707116610195327071165, Lot Numbers: 24ABK094; j) DYNJ909730: UDI/DI case 4019532746453110195327464530, Lot Numbers: 24CBS071, 24EBI597

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
358 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