Agency classClass IIOur severity:Severe FDA (Devices)·Z-2811-2018·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 connection.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a medical device defect that could lead to significant injury or property damage (leak/separation) corresponds to a severity score of 4 (Severe).

Plain-English summary

ICU Medical de Mexico, S.A. de C.V. is expanding the scope of a previously initiated recall to include additional 61 cm (24") Smallbore Ext Set with 6-Port NanoClave Manifold. The recall is 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 product is identified by Item Number 011-AM6133. The recall covers 100 pouches from two specific lots: Lot Number 3493948 and Lot Number 3498107, both with an expiration date of 07/01/2022. The distribution pattern includes US distribution to Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington, as well as worldwide distribution to Belgium, France, and Germany.

Healthcare facilities and consumers should stop using the affected I.V. administration sets immediately. Users should check their inventory for the specific item number and lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the manufacturer according to their instructions.

The recalled product

Product: 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
Manufacturer: ICU Medical de Mexico, S.A. de C.V.
Category: Medical Device — I.V. Administration Sets
Hazard: leak
separation
Affected units: 100

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 (5)

Item Number 011-AM6133. a. Lot Number 3493948
UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3493948
Expiration Date 07/01/2022
b. Lot Number 3498107
UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3498107

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.

See all →

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

Same hazard · leak