Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M100 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 involves a Class II medical device with a defect (connector breakage) that leads to leakage of blood or liquid, which constitutes a significant injury risk under the rubric for structural defects or significant injury reports.
Plain-English summary
Gambro Renal Products, Incorporated is conducting a field action for Prismaflex M100 dialysis sets (Product number 106697). The affected units are packaged in plastic pouches, with four pouches per carton box.
The recall was initiated due to breakages of connectors that can result in the leakage of liquid or blood. The affected product includes batch numbers 12A0401G to 14C2802G with expiry dates ranging from 01/2014 to 03/2016.
A total of 401,451 units were distributed worldwide. The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Category
- Medical Device — Dialysis
- 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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