EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic… recallZ-0363-2019 · Baxter Healthcare Corporation · initiated Sep 12, 2018

Why it was recalled

Potential ability to leak once used for compounding.

FDA root cause category: Process control

What the company is doing

An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail. Baxter is asking customers to: 1. Locate and remove all affected product from your facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email. Notification Effectiveness: 100%. The non-responding customers will be contacted via telephone. Expansion on 02/19/2019, Baxter notified customers (and additional customers) of recall and additional lots included.

Recall details

Recall number

Z-0363-2019

Recall class

Class II

Status

Terminated

Initiated by the company

Sep 12, 2018

Posted by the FDA

Nov 2, 2018

Recalling firm

Baxter Healthcare Corporation

Quantity

158,163 units

Product code

KPE

FDA submissions

K900585

Distribution

Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.

Product description

EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

Other devices under the same FDA submission

8 devices cleared under K900585 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• EXACTAMIX H938740

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall1,350 reports
• EXACTAMIX H938738

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall1,180 reports
• EXACTAMIX H938739

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall972 reports
• EXACTAMIX H938741

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall710 reports
• EXACTAMIX H938737

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall607 reports
• EXACTAMIX H938742

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  93 reports
• EXACTAMIX H938743

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  87 reports
• EXACTAMIX H938735

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 81240).

• Z-0364-2019 · Terminated
  EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administ…
• Z-0365-2019 · Terminated
  EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr…
• Z-0366-2019 · Terminated
  EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr…
• Z-0367-2019 · Terminated
  EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr…