FDA-Device2024-09-18Class II

Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A

MEDLINE INDUSTRIES, LP - Northfield
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.

Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Affected count
19 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3108-2024

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