Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Compromise
Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential packaging compromise without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Teleflex Medical Inc. is recalling Pleur-Evac Adult-Ped Wet chest drainage devices, product code A-8000I-06. The recall involves 1,812 units distributed worldwide, including in the United States, Puerto Rico, and various international locations. The specific reason for the recall is the potential for the sterile packaging to be compromised.
The affected devices are used for chest drainage to evacuate air and fluid from the chest cavity or mediastinum. The recall covers multiple lot numbers, including 74A1801125, 74A1902739, and others listed in the agency records. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices if the packaging integrity is in question. Consumers are advised to contact their healthcare provider or the manufacturer for further instructions regarding the affected products.
The recalled product
- Product
- Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish an
- Manufacturer
- TELEFLEX MEDICAL INC
- Category
- Medical Device — Chest Drainage
- Affected units
- 1,812
Distribution
Part of a larger recall action
This product is one of 2 recalled by TELEFLEX MEDICAL INC 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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