The Recall Desk
SevereFDA (Devices)·Z-0203-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect involves a critical functional component like a seal in a medical device.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 8.5-inch smallbore intravascular administration sets. The recall involves a total of 304,735 units of the product, which is a single-use, sterile device used to administer fluids to a patient's vascular system. The affected product is identified by Lot Number 4557524.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the 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.

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 stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30)50(10)4557524. The Intravascular Administration Set is a single use, sterile, non-pyrogenic dev
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 (1)

  • Lot Number:4557524.

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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

See all →

Same hazard · manufacturing defect

See all →