DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Recall
- Recall Number
- Z-2800-2018
- Event Number
- 80460
- Firm
- ICU Medical de Mexico, S.A. de C.V. Avenida Cuarzo 250 Ensenada Ejido Maneadero Mexico
- FEI Number
- 3003807466
- Product Code
- FMG
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 1, 2018
- Terminated
- January 26, 2024
Description
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
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.
ICU Medical notified customers of the recall on about 03/01/2018 via URGENT: Medical Device Recall Notification. The notification informed customers that this was an update and expansion to previously initiated recall. Instructions included to inspect inventory for affected devices, arrange for the return of affected devices, and complete and return the Urgent Medical Device Recall Notification Response Form to [email protected].
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
122 pouches