Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Risk
Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterile packaging may be compromised, creating a risk of infection (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical Inc. is recalling specific lots of Pleur-Evac Adult-Ped Wet chest drainage devices (product code A-8000I). The recall is due to a potential for the sterile packaging to be compromised. This product is used to evacuate air and/or fluid from the chest cavity or mediastinum and to help re-establish normal intra-thoracic pressure gradients.
The affected units were distributed worldwide, including in the United States, Puerto Rico, and various international locations. The recall covers 204,644 units across numerous lot numbers listed in the official FDA record. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and consumers should check their inventory for the specific lot numbers identified in the FDA recall notice Z-2748-2020. If the product is found, it should be stopped from use and returned to the manufacturer or disposed of according to local regulations. Patients currently using these devices should consult their healthcare provider for guidance on alternative treatments or monitoring.
The recalled product
- Product
- Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - 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 and main
- Manufacturer
- TELEFLEX MEDICAL INC
- Category
- Medical Device — Chest Drainage
- Affected units
- 204,644
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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