Agency classClass IIOur severity:High FDA (Devices)·Z-2810-2018·Announced 2018-08-22

ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold.

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 involves a medical device with a risk of harm (leak or separation) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

ICU Medical de Mexico, S.A. de C.V. is expanding the scope of a previously initiated recall to include additional 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer. The recall involves 350 pouches of the product.

The recall is being conducted due to the potential for the device to develop a leak or for separation to occur between the female luer and the NanoClave manifold. The affected lots are 3484175, 3493946, and 3498103, all with an expiration date of 07/01/2022.

The product was distributed in the United States to Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington, as well as to Belgium, France, and Germany. Healthcare facilities and consumers should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product: 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.
Manufacturer: ICU Medical de Mexico, S.A. de C.V.
Category: Medical Device — I.V. Administration Sets
Hazard: leak
separation
Affected units: 350

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 (7)

Item Number 011-AM6132. a. Lot Number 3484175
UDI Number (01) 1 0840619 09743 6 (17) 220601 (30) 50 (10) 3484175
Expiration Date 07/01/2022
b. Lot Number 3493946
UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3493946
c. Lot Number 3498103
UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3498103

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 20 recalled by ICU Medical de Mexico, S.A. de C.V. 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 20 products in this recall →

Same manufacturer · ICU Medical de Mexico, S.A. de C.V.

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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
High
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
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Same hazard · leak