Gambro Recalls Polyflux Revaclear Dialyzers Due to Packaging Defects
Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.
What this means for you
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) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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 distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, Barbados, Bermuda, the Bahamas, the Dominican Republic, and Saint Lucia.
The specific lot numbers involved range from C412120501 to C412127501, C413100101 to C413129601, and C414100101 to C414119301, as well as Lot C414120001. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Polyflux Revaclear Dialyzer, Model Number 110633. 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. C412120501 to C412127501
- C413100101 to C413129601
- C414100101 to Lots C414119301 and Lot C414120001
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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