Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect (connector breakage) that results in the leakage of blood or liquid, posing a significant risk of injury or infection, which aligns with the criteria for a Severe (Score 4) classification.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prismaflex M150 dialysis sets (Product number 109990). The recall covers 401,451 units distributed worldwide. Each set is packaged in a plastic pouch, with 4 pouches per carton box.
The field action was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. The affected batch numbers range from 12A0304G to 14C2706, with expiry dates from 01/2014 to 03/2016.
Healthcare facilities and users should stop using the affected Prismaflex M150 sets and contact Gambro Renal Products for instructions on return or replacement.
The recalled product
- Product
- Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Hazard
- 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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