Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.
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 is classified as FDA Class II and involves a structural defect (connector breakage) that results in leakage of blood, which poses a significant risk of injury.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prismaflex HF 1000 dialysis sets (Product number 107140). The recall involves 401,451 units distributed worldwide. The affected products are identified by batch numbers 12A0504 to 14C3105 and have expiration dates ranging from 01/2014 to 03/2016.
The recall was initiated due to breakages of connectors on the Prisma and Prismaflex sets. These breakages can result in the leakage of liquid or blood. The agency has classified this as a Class II recall.
Healthcare facilities and consumers should stop using the affected Prismaflex HF 1000 sets and contact Gambro Renal Products for further instructions on how to return or dispose of the units.
The recalled product
- Product
- Prismaflex HF 1000. Product number 107140. 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.
See all 15 products in this recall →Related recalls
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