Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-2811-2018

U.S. FDA — Device Enforcement · Mexico · 2018-03-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2811-2018
Date of alert
2018-03-01
Country / jurisdiction
Mexico
Risk level
Class II
Risk type
recall
Brand
ICU Medical de Mexico, S.A. de C.V.
Product category
device
Product type
Devices
Reported risk: ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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