Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M100 PRE pump infusion 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 is classified as FDA Class II and involves a medical device defect (connector breakage) that results in the leakage of blood or liquid, posing a significant risk of injury or infection.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prisma M100 PRE pump infusion sets, product number 107791. The recall involves 401,451 units distributed worldwide. The sets are packaged in plastic pouches, with four pouches per carton box.
The recall was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. The affected batch numbers range from 12A2305 to 13D0902, with expiry dates from 01/2014 to 04/2015.
Healthcare facilities and users should stop using the affected infusion sets and contact Gambro Renal Products for instructions on how to return or dispose of the product.
The recalled product
- Product
- Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Category
- Medical Device — Infusion Set
- 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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