Gambro Recalls Prismaflex M60 Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M60 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) but the source text does not report any 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 Prismaflex M60 sets (Product number 106696) due to a field action initiated by the company. The recall covers 401,451 units that were distributed worldwide. Each set is packaged in a plastic pouch, with 4 pouches per carton box.
The recall was initiated because of breakages of connectors on the Prisma and Prismaflex sets. These breakages can result in the leakage of liquid or blood. The affected batch numbers range from 12A0605 to 14A2011, with expiry dates from 01/2014 to 01/2016.
The source text does not specify specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Category
- Medical Device — Dialysis
- 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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