Prodimed Combicath catheters recalled due to sterility assurance concerns
Prodimed is recalling 1,460 Combicath catheters nationwide because the company cannot assure the products are sterile.
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 3/5 (High).
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 risk-of-harm product (sterility failure) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Prodimed Plastimed Division is recalling 1,460 units of Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS). The specific product is the COMBICATH PE 90 cm, identified by Product Code 58229 19. The recall covers all lots within their expiry dates and the products were distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the root cause of the sterility issue, nor does it report any specific illnesses or injuries associated with the use of these devices.
Healthcare providers and facilities that have received these products should stop using them and contact Prodimed Plastimed Division for further instructions on return or disposal. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
- Manufacturer
- Prodimed Plastimed Division
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 1,460
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
FDA (Devices) · 2020-07-15
- 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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- SevereProdimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues
FDA (Devices) · 2020-07-15
- SevereProdimed Combicath Catheters Recalled for Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
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