Cordis Recalls POWERFLEX P3 Catheters Due to Potential Seal Voids
Cordis is recalling one lot of POWERFLEX P3 PTA Dilation Catheters due to potential voids in the proximal seal area.
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 medical device with a structural defect (voids in the seal) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Cordis Corporation is recalling one lot of POWERFLEX P3 PTA Dilation Catheters, reference number 420-6020S. The recall involves 89 units from Lot 82155955, which have a use-by date of June 30, 2021.
The recall was initiated due to the potential for body or shaft voids in the proximal seal area of the catheter. This defect could compromise the integrity of the device during use.
The affected units were distributed in the United States and the United Kingdom. Healthcare providers and facilities should check their inventory for this specific lot number and reference number. If the product is found, it should be removed from use and returned to Cordis Corporation according to their instructions.
The recalled product
- Product
- Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Catheter
- Affected units
- 89
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 (2)
- Lot 82155955
- Use by date 2021-06-30
Distribution
Distribution scope not specified by the agency.
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