The Recall Desk
HighFDA (Devices)·Z-2207-2014·Announced 2014-08-20

Gambro Recalls X-MARS Sets Due to Connector Breakage and Leakage

Gambro Renal Products is recalling X-MARS 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 with a risk of harm (leakage of blood or liquid) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Gambro Renal Products, Incorporated is recalling the X-MARS Set, a component of the MARS Treatment Kit Type 1116/1 X-MARS US (Product Number 800541). The recall involves 401,451 units that were distributed worldwide.

The field action was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. The affected product is identified by Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, and Expiry Date 02/2017.

Healthcare providers and consumers should stop using the affected X-MARS Sets and contact Gambro Renal Products for further instructions on how to return or replace the product.

The recalled product

Product
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Manufacturer
Gambro Renal Products, Incorporated
Category
Medical Device — Dialysis / Renal
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 1116/1 X-MARS US
  • Batch Number 0000020229
  • Expiry Date 02/2017

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

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Same hazard · leakage

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