Prodimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues
Prodimed is recalling Combicath Paediatric catheters due to a lack of assurance of sterility. The recall covers 2,580 units distributed nationwide.
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 with a sterility assurance issue, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Prodimed Plastimed Division is recalling 2,580 units of Combicath Paediatric catheters for blind protected distal bronchial sampling (Product Code: 58 223 19). The recall was initiated because of a lack of assurance of sterility for the affected devices.
The affected products were distributed nationwide. The recall includes all lots within their expiry dates. No specific lot numbers or dates are provided in the source text.
Healthcare providers and consumers should stop using these catheters and contact Prodimed Plastimed Division for further instructions or a return.
The recalled product
- Product
- Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
- Manufacturer
- Prodimed Plastimed Division
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 2,580
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
Same manufacturer · Prodimed Plastimed Division
See all →- HighProdimed Combicath Catheters Recalled for Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
- HighProdimed Combicath Catheters Recalled Due to Sterility Assurance Concerns
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- SevereProdimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues
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- HighProdimed Combicath catheters recalled due to sterility assurance concerns
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- SevereProdimed Combicath Catheters Recalled for Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
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