Gambro Recalls Prismaflex HF 1400 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.
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 defect (connector breakage) that poses a risk of harm (leakage of blood or liquid) to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prismaflex HF 1400 dialysis sets (Product number 107142) due to a defect in the connectors. The field action was initiated because the connectors may break, resulting in the leakage of liquid or blood.
The affected product is packaged in plastic pouches, with four pouches per carton box. The recall covers batch numbers 12A1005 to 14C1106 with expiry dates ranging from 01/2014 to 03/2016. A total of 401,451 units were distributed worldwide.
The source text does not specify specific instructions for consumers or healthcare providers regarding the disposal or return of these units. Users of these dialysis sets should contact their healthcare provider or the manufacturer for further guidance on how to proceed.
The recalled product
- Product
- Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Category
- Medical Device — Dialysis Sets
- Affected units
- 401,451
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Gambro Renal Products, Incorporated 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.
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