Prodimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues
Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
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 significant risk of infection or serious injury.
Plain-English summary
Prodimed Plastimed Division is recalling 180 units of Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling. The specific product code is 58 223 19US, and the devices are 35 cm x 1.9 mm in size. The recall covers 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 devices are sterile, which is a critical requirement for medical devices used in invasive procedures.
The affected devices were distributed nationwide. Healthcare providers and facilities that have received these specific catheters should stop using them and contact the recalling firm for further instructions on how to handle the returned units.
The recalled product
- Product
- Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
- Manufacturer
- Prodimed Plastimed Division
- Affected units
- 180
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 Paediatric Catheters Recalled for 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
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