Gambro Recalls Prisma M100 Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M100 sets because connector breakages can cause liquid or blood to leak.
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 with a risk of harm (leakage of blood or liquid) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prisma M100 sets, product number 104182. The affected units are packaged in plastic pouches, with four pouches per carton box. The recall covers batch numbers 12A3005 to 14A1703 with expiry dates ranging from 01/2014 to 01/2016.
The field action was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. The source text does not specify the exact number of affected units, the specific distribution locations, or any reported injuries or illnesses.
Healthcare facilities and users should stop using the affected Prisma M100 sets and contact Gambro Renal Products for instructions on how to return or dispose of the product.
The recalled product
- Product
- Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- 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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