Gambro Recalls Prisma HF1000 Presets Due to Connector Breakage
Gambro Renal Products is recalling Prisma HF1000 presets 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), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prisma HF1000 presets (new design), product number 107639. The affected units are packaged in plastic pouches, with four pouches per carton box. The recall covers batch numbers 12A1303 to 13E3104 with expiry dates ranging from 01/2014 to 05/2015.
The field action was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. A total of 401,451 units were distributed worldwide.
Healthcare facilities and users should stop using the affected Prisma HF1000 presets and contact Gambro Renal Products for further instructions on the field action.
The recalled product
- Product
- Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Category
- Medical Device — Hemodialysis
- 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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