Z-2801-2018 Class II Terminated
FDA device recall Z-2801-2018 was initiated by ICU Medical de Mexico, S.A. de C.V. on March 1, 2018 and is designated Class II. 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 … The recall status is terminated (terminated January 26, 2024). Affected quantity: 50 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- March 1, 2018
- Termination Date
- January 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 pouches
Product Description
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
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.
Distribution Pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
Code Information
Item Number 011-AM3010. Lot Number 3424312, UDI Number (01) 1 0840619 09487 1 (17) 220301 (30) 50 (10) 3424312, Expiration Date 03/01/2022