Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect (connector breakage) that results in the leakage of blood or liquid, posing a significant risk of injury or infection, which aligns with the criteria for a Severe (Score 4) classification.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prismaflex M150 dialysis sets (Product number 109990). The recall covers 401,451 units distributed worldwide. Each set is packaged in a plastic pouch, with 4 pouches per carton box.
The field action was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. The affected batch numbers range from 12A0304G to 14C2706, with expiry dates from 01/2014 to 03/2016.
Healthcare facilities and users should stop using the affected Prismaflex M150 sets and contact Gambro Renal Products for instructions on return or replacement.
The recalled product
- Product
- Prismaflex M150. Product number 109990. 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
Same manufacturer · Gambro Renal Products, Incorporated
See all →- HighGambro Recalls Prisma M 60 PRE Sets Due to Connector Breakage
FDA (Devices) · 2014-08-20
- SevereGambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage
FDA (Devices) · 2014-08-20
- HighGambro Recalls Prisma M 100 PRE Sets Due to Connector Breakage
FDA (Devices) · 2014-08-20
- HighGambro Recalls Prisma HF1000 Presets Due to Connector Breakage
FDA (Devices) · 2014-08-20
- HighGambro Recalls Prismaflex HF 1400 Dialysis Sets Due to Connector Breakage
FDA (Devices) · 2014-08-20
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- ModeratePrismaflex M150 sets recalled over a deaeration chamber that may dislodge
FDA (Devices) · 2026-02-11
- HighBaxter Gambro Cartridge Blood Set Recalled for Potential Leak Risk
FDA (Devices) · 2021-06-02
- HighGambro Recalls Polyflux Revaclear Dialyzers Due to Packaging Defects
FDA (Devices) · 2014-12-10
- HighGambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks
FDA (Devices) · 2014-05-28
- HighBaxter Gambro Cartridge Blood Set Recalled for Tubing Disconnection Risk
FDA (Devices) · 2020-06-10
- SevereGambro Polyflux Revaclear Max Dialyzers Recalled for Internal Blood Leaks
FDA (Devices) · 2014-05-28