Agency classClass IIOur severity:High FDA (Devices)·Z-1344-2018·Announced 2018-04-18

ICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar

ICU Medical is recalling 250 pouches of 7-inch intravascular administration sets because they were manufactured with an incorrect spin collar.

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 is classified as FDA Class II for a medical device with a manufacturing defect (incorrect spin collar). No specific injuries or illnesses are reported in the source text, but the defect in a sterile intravascular device presents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 250 pouches of 7-inch Intravascular Administration Sets (Item AH7262). The affected lots are 3483247, 3484722, and 3489328. These single-use, sterile devices are used to administer fluids from a container to a patient's vascular system.

The recall was initiated because the infusion sets were manufactured with an incorrect spin collar. The agency has classified this recall as Class II.

The affected products were distributed nationwide in the United States to Arizona, California, Colorado, Florida, South Carolina, and Texas, as well as to Canada and Japan. Consumers and healthcare facilities should stop using the affected products and contact ICU Medical for further instructions.

The recalled product

Product: 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Sets
Hazard: manufacturing-defect
Affected units: 250

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 (6)

Lot number 3483247
UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3483247
lot number 3484722
UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3484722
and lot number 3489328
UDI (01) 0 0887709 08949 5 (17) 220701 (30) 01 (10) 3489328.

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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Same hazard · manufacturing defect