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Terminated

EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.

FDA Recall Z-0167-2020 · Posted None

Recall StatusTerminated
Product CodeLHI
Date Initiated2019-09-18
Date Terminated2021-02-16
Product Quantity11,389,800 units total

Reason for Recall

Potential ability to leak once used for compounding.

Firm Action

Baxter Healthcare Corporation notified customers on about 09/18/2019, via "Urgent Product Recall" letter. The letter informed customers that certain lot numbers of the EXACTAMIX Empty EVA Bags have the potential ability to leak once used for compounding. Customers were instructed to locate and remove all affected product lots from your facility, contact Baxter Healthcare Center for Service to arrange for return and credit, complete and return the provided Baxter customer reply form via fax to 224-270-5457 or scanning and e-mailing it to [email protected], and notify customers or affected personnel/departments if the product was further distributed. For customers who purchased affected product from a distributor, contact your distributor for return and credit. Questions can be directed to Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - UD Nationwide including 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of Canada, Australia, New Zealand, Singapore, Korea, Taiwan, Thailand, Hong Kong, Brazil, Columbia, Mexico, Chile, Uruguay, Dominican Republic, Panama, Bermuda.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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