Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss
Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported adverse events, which aligns with the rubric criteria for a Severe rating (Score 4).
Plain-English summary
Medline Industries, LP is recalling 350 units of 1500 cc semi-rigid suction liners manufactured between September 2023 and November 2023. The recall involves four specific pack numbers: MINOR BREAST (DYNJ908104B), PLASTIC MAJOR (DYNJ908106B), ABDOMINOPLASTY W/LIPO SUCTION (DYNJ909946), and PLASTIC (DYNJ909951). These products were distributed nationwide in the United States as well as in Canada and Panama.
The recall is being issued due to reported adverse events related to the potential loss of suction or low suction during intermittent suction use. This defect may compromise the intended function of the medical device.
Healthcare providers and consumers should check their inventory for the specific lot numbers and UDI/DI codes listed in the recall notice. If the affected products are in use, they should be removed from service and returned to Medline Industries, LP for further instructions.
The recalled product
- 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
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Suction Liners
- Affected units
- 350
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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