Prodimed Combicath Catheters Recalled Due to Sterility Assurance Concerns
Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of 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 is classified as FDA Class II, and the hazard involves a lack of sterility assurance for an invasive medical device, which poses a risk of harm even without reported injuries.
Plain-English summary
Prodimed Plastimed Division is recalling Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL). The specific product model is COMBICATH PE 85 cm x 4.0 mm, catalog number 58124 40US. The recall involves 39,800 units distributed nationwide, covering all lots within their expiry dates.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the catheters are sterile, which is a critical requirement for medical devices used in invasive procedures.
Healthcare providers and facilities that have purchased these catheters should stop using them and contact Prodimed Plastimed Division for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
- Manufacturer
- Prodimed Plastimed Division
- Category
- Medical Device — Catheters
- Affected units
- 39,800
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Prodimed Plastimed Division 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.
See all 6 products in this recall →Related recalls
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