Agency classClass IIOur severity:High FDA (Devices)·Z-0185-2014·Announced 2013-11-20

Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

Fresenius Medical Care is recalling 24,202 cases of Combiset Blood Lines with BVM for hemodialysis. The recall addresses a risk of blood loss if connections are not tightened correctly.

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 3/5 (High).

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 where a defect can lead to blood loss, a risk-of-harm condition. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 24,202 cases of Combiset Blood Line with BVM for Hemodialysis use, Catalog Number 03-2965-9. The product is intended for use as the extracorporeal blood circuit during hemodialysis with conventional and high flux negative pressure hemodialyzer equipment. The recall covers all lot codes and includes products distributed nationwide in the United States and in Canada.

The recall was initiated because bloodline connections that are not tightened per the instructions in the operator's manual may disconnect. Such disconnections can lead to blood loss. The source text does not report any specific injuries, illnesses, or fatalities associated with this recall.

Healthcare facilities and users should stop using the affected blood lines and follow the updated instructions for use provided by the manufacturer to ensure connections are properly tightened.

The recalled product

Product: Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Hemodialysis Equipment
Hazard: blood-loss
device-disconnection
Affected units: 24,202

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 (1)

All lot codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Fresenius Medical Care Holdings, Inc. 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 3 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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