Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1347-2018·Announced 2018-04-18

ICU Medical Recalls Infusion Sets with Incorrect Spin Collars

ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect (incorrect spin collar) is a manufacturing error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ICU Medical, Inc. is recalling 7,600 pouches of 14 cm (5.5") Smallbore Ext Set w/SURPLUG Nano T-Connector, Clamp, Rotating Luer, Item IR-NG31481B. The recall is due to the infusion sets being manufactured with an incorrect spin collar.

The affected sterile, single-use intravascular administration sets were distributed nationwide in the United States to Arizona, California, Colorado, Florida, South Carolina, and Texas, as well as to Canada and Japan. The recall covers four specific lot numbers: 3422861, 3489493, 3498769, and 3498773.

Healthcare providers and consumers should stop using the affected infusion sets and contact ICU Medical for further instructions or a replacement.

The recalled product

Product: 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Sets
Hazard: manufacturing-defect
Affected units: 7,600

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 (8)

Lot number 3422861
UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861
lot number 3489493
UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3489493
lot number 3498769
UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498769
and lot number 3498773
UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498773.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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 →

Same manufacturer · ICU Medical, Inc.

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