The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1721-2022·Announced 2022-09-21

Extension Set Recall Due to Connector Housing Manufacturing Defect

ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.

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: FDA Class II medical device recall with a manufacturing defect affecting connector housing. No reported illnesses or injuries, but the visible gap represents a risk-of-harm to medical device function and sterility in a healthcare setting, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 6.5-inch (17 cm) Smallbore Bifurcated Extension Sets with MicroClave Clear, 2 Check Valves, and Luer Lock due to a manufacturing defect. The defect results in a visible gap between the top and bottom of the connector housing.

These extension sets are medical devices used in infusion therapy settings. A gap in the connector housing could potentially affect device function and compromise sterility. The FDA classified this as a Class II recall. No illnesses or injuries have been reported at this time.

Approximately 5.8 million affected units (5,795,989 units according to the manufacturer) have been distributed across all U.S. states and territories, and internationally to countries including Canada, Japan, United Kingdom, and others. Multiple product numbers and lot numbers are affected as detailed by ICU Medical.

Healthcare facilities and patients should verify their inventory against the affected product and lot numbers. Contact ICU Medical for instructions on product return or destruction. Do not use affected extension sets until the issue is resolved.

The recalled product

Product
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion / Extension Sets
Hazard
Affected units
5,795,989

Distribution

Distributed in 53 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

See all →

Same hazard · connector gap

See all →

Similar recalls