Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns
Prodimed Plastimed Division is recalling 300 Combicath catheters nationwide due to a lack of assurance of sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance issues in invasive medical devices are categorized as Severe.
Plain-English summary
Prodimed Plastimed Division is recalling 300 units of Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS). The specific product code is 58229 19US, and the recall covers all lots within expiry. The distribution pattern is nationwide.
The reason for the recall is 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 received these catheters should stop using them and contact Prodimed Plastimed Division for instructions on return or disposal. Patients who have already had procedures using these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
- Manufacturer
- Prodimed Plastimed Division
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 300
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 for Sterility Assurance Concerns
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- HighProdimed Combicath Catheters Recalled Due to Sterility Assurance Concerns
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- HighProdimed Combicath catheters recalled due to sterility assurance concerns
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