Z-3108-2024 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Recall Details

Product Type
Devices
Report Date
September 18, 2024
Initiation Date
June 27, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Code Information

DYNJ909451A, UDI/DI case 40195327478392, UDI/DI each 10195327478391, Lot Numbers: 23LMI232