Gambro Recalls Polyflux Dialyzers Due to Potential Packaging Tears
Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.
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 where a compromised sterile barrier poses a risk of harm (infection), but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Gambro Renal Products Inc is initiating a field action for Polyflux Revaclear Dialyzers and Polyflux Revaclear Max Dialyzers. These single-use devices are intended for the treatment of acute and chronic renal failure by hemodialysis.
The recall is due to potential tears in the individual packaging that may compromise the sterile barrier. The affected units include approximately 20 million dialyzers with Model Number 110634. The specific lot numbers involved are C412207001 to C412209101, C413200101 to C413206001, and C414200101 to C414206001.
The products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Canada, Barbados, Bermuda, the Bahamas, the Dominican Republic, and Saint Lucia. Users should check their inventory for the affected lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
- Manufacturer
- Gambro Renal Products Inc
- Affected units
- 20
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 (3)
- Lot No C412207001 to C412209101
- C413200101 to C413206001
- C414200101 to C414206001
Distribution
Part of a larger recall action
This product is one of 2 recalled by Gambro Renal Products Inc 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 2 products in this recall →Related recalls
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See all →- HighGambro Recalls Polyflux Revaclear Dialyzers Due to Packaging Defects
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