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Recall Observatory FDA recall evidence

Device product

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

Z-3113-2024

June 27, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95128
Status
Ongoing
Classification
Class II
Quantity
350 units
Official record key
device-enforcement:Z-3113-2024

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.