Z-3113-2024 Class II Ongoing
FDA device recall Z-3113-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Jun 27, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 350 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Jun 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 350 units
Product Description
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ908106B; c) ABDOMINOPLASTY W/LIPO SUCTION, Pack Number DYNJ909946; d) PLASTIC, Pack Number DYNJ909951
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
a) DYNJ908104B: UDI/DI case 40195327507115, UDI/DI each 10195327507114, Lot Numbers: 23LBT869, 24BBQ730; b) DYNJ908106B: UDI/DI case 40195327507139, UDI/DI each 10195327507138, Lot Numbers: 24ABB087, 24CBM739, 24EBH234; c) DYNJ909946: UDI/DI case 40195327512652, UDI/DI each 10195327512651, Lot Numbers: 23LBD934, 24DBB806; d) DYNJ909951: UDI/DI case 40195327512904, UDI/DI each 10195327512903, Lot Numbers: 23LBD932, 24ABP740
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3113-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026