Home / Recalls / ICU Medical de Mexico, S.A. de C.V. / Z-2797-2018

Z-2797-2018 Class II Terminated

Recalled by ICU Medical de Mexico, S.A. de C.V. — Ejido Maneadero

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
81 pouches

Product Description

20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s 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.

Distribution Pattern

US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.

Code Information

Item Number 011-AM3002. a. Lot Number 3326545, UDI Number (01) 1 0640619 09275 4 (17) 210901 (30) 50 (10) 3326545, Expiration Date 09/01/2021; b. Lot Number 3459161, UDI Number (01) 1 0840619 09275 4 (17) 220501 (30) 50 (10) 3459161, Expiration Date 05/01/2022

Other recalls by ICU Medical de Mexico, S.A. de C.V.

  • Z-2808-2018 Class II — 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClav (March 1, 2018)
  • Z-2811-2018 Class II — 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroCla (March 1, 2018)
  • Z-2816-2018 Class II — 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating L (March 1, 2018)
  • Z-2812-2018 Class II — 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Ye (March 1, 2018)
  • Z-2813-2018 Class II — 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating (March 1, 2018)
  • Z-2800-2018 Class II — DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (March 1, 2018)
  • Z-2815-2018 Class II — 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Ye (March 1, 2018)
  • Z-2799-2018 Class II — 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoC (March 1, 2018)
  • Z-2814-2018 Class II — 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp (March 1, 2018)
  • Z-2804-2018 Class II — 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoC (March 1, 2018)