The Recall Desk
HighFDA (Devices)·Z-0069-2019·Announced 2018-10-10

ICU Medical Bifuse Transfer Set Recalled Due to Missing Blood Filter

ICU Medical is recalling 2,361 Bifuse Transfer Sets because a design change removed the blood filter, creating a risk of use as a blood transfusion set.

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 risk-of-harm medical device where the absence of a blood filter could lead to injury if used for transfusions, but no injuries or illnesses have been reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 2,361 units of the 14-inch (36 cm) Bifuse Transfer Set with Rotating Luer (REF: 14237-28). The affected lots are 85-540-SJ, 86-189-SL, and 86-911-SJ. These devices were distributed in the United States to the states of New York, Alabama, California, Mississippi, Pennsylvania, Georgia, Michigan, North Carolina, Wisconsin, Illinois, Washington, Utah, and Florida.

The recall was initiated because a design change converted the device from a blood set with a filter to a transfer set without a filter, while retaining the same listing number. There is a risk that customers may not be aware of this change and might use the transfer set for blood transfusions without realizing that the necessary blood filter is not included.

Healthcare facilities and customers who have received these specific lots should stop using the devices and contact ICU Medical for instructions on return or replacement.

The recalled product

Product
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system t
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
Affected units
2,361

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)

  • lots: 85-540-SJ
  • 86-189-SL
  • 86-911-SJ

Distribution

Distributed in 13 states:

Related recalls

Same manufacturer · ICU Medical, Inc.

See all →

Same hazard · missing filter

See all →