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.
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 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…
- Manufacturer
- ICU Medical, Inc.
- 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
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