Recall Z-3105-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K. 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-27
- Firm location
- Northfield, IL, United States
Product description
Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.