ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
What this means for you
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 injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical de Mexico, S.A. de C.V. is expanding the scope of a previously initiated recall to include additional I.V. Administration Sets with NanoClave manifolds. The recall involves the PROXIMALE 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. A total of 532 pouches are affected.
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 include 3358780, 3365174, 3367857, 3497708, and 3508531, with expiration dates ranging from 11/01/2021 to 08/01/2022.
The products were distributed in the United States to Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington. Worldwide distribution included Belgium, France, and Germany. Consumers and healthcare facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
- Manufacturer
- ICU Medical de Mexico, S.A. de C.V.
- Hazard
- Affected units
- 532
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 (13)
- Item Number 011-AM6118. a. Lot Number 3358780
- UDI Number (01)01 0840619 09319 (17) 211101 (30) 50 (10) 3358780
- Expiration Date 11/01/2021
- b. Lot Number 3365174
- UDI Number (01) 01 0840619 09319 5 (17) 211101 (30)50 (10) 3365174
- c. Lot Number 3367857
- UDI Number (01) 01 0840619 09319 8 (17) 211101 (30) 01 (10) 3387857
- d. Lot Number 3497708
- UDI Number (01) 1 0840619 09319 5 (17) 220701 (30) 50 (10) 3497708
- Expiration Date 07/01/2022
- e. Lot Number 3508531
- UDI Number (01) 1 0840619 09319 5 (17) 220801 (30) 50 (10) 3508531
- Expiration Date 08/01/2022
Distribution
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 →Related recalls
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