Recall Z-2800-2018— ICU Medical de Mexico, S.A. de C.V.
Class II · Terminated
Class II FDA medical device recall by ICU Medical de Mexico, S.A. de C.V., initiated 2018-03-01, terminated 2024-01-26. It names one FDA 510(k) clearance: K964435. Product: 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.. Reason: 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..
- Recalling firm
- ICU Medical de Mexico, S.A. de C.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-01
- Terminated
- 2024-01-26
- Firm location
- Ejido Maneadero, Mexico
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.