The Recall Desk
SevereFDA (Devices)·Z-2206-2014·Announced 2014-08-20

Gambro Recalls PrisMARS Kits Due to Connector Breakage and Leakage

Gambro Renal Products is recalling PrisMARS Kits 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 defect that can cause leakage of blood or liquid, which constitutes a significant injury risk.

Plain-English summary

Gambro Renal Products, Incorporated is recalling PrisMARS Kits, which are components of the MARS Treatment Kit Type 1115/1 PrisMARS US. The recall involves 401,451 units distributed worldwide. The affected products are identified by Product Number 800480, with batch numbers ranging from 0000017412 to 0000019827 and expiry dates from 06/2014 to 05/2016.

The field action was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. This defect poses a risk to patients using the MARS treatment system.

Healthcare providers and facilities should stop using the affected PrisMARS Kits immediately. Users should contact Gambro Renal Products for instructions on how to return or dispose of the recalled units.

The recalled product

Product
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Manufacturer
Gambro Renal Products, Incorporated
Category
Medical Device — Dialysis Equipment
Hazard
Affected units
401,451

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Number MARS Treatment Kit Type 1115/1 PrisMARS US
  • Batch 0000017412 - 0000019827
  • Expiry Date 06/2014 to 05/2016

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 →

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Same manufacturer · Gambro Renal Products, Incorporated

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Same hazard · leakage

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