The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0189-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

ICU Medical is recalling specific lots of 9-inch Smallbore Bifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as a seal defect in a sterile medical device) are categorized as Severe (Score 4), as they are not Class I but involve a risk of harm.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 9-inch (23 cm) Smallbore Bifuse Extension Sets. The affected products are sterile, single-use intravascular administration sets designed to provide access for the administration of fluids from a container to a patient's vascular system. The recall involves a total of 304,735 units across two specific lot numbers: 4536611 and 4557492.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the affected sets. This defect may inhibit a proper seal with the NanoClave spike. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected products were distributed worldwide, including nationwide in the United States and in several international countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and distributors should check their inventory for the specific lot numbers listed and stop using the affected sets. Patients who have received these sets should contact their healthcare provider for further guidance.

The recalled product

Product
9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709052953(17)241201(30)50(10)4536611;(01)10887709052953(17)250101(30)50(10)4557492 The…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard

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 (2)

  • Lot Numbers:4536611
  • 4557492.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 99 recalled by ICU Medical, 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 99 products in this recall →

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