EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be

FDA device recall Z-0366-2019 · posted 2018-11-02 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

Potential ability to leak once used for compounding.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

KPE

Quantity affected

456,071 units

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,

Date initiated

2018-09-12

Date posted

2018-11-02

Date terminated

2020-11-02

Location

Deerfield, IL

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