FDAClass IINovember 7, 2018

EXACTAMIX Empty EVA Bags recall

EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient…

Why was EXACTAMIX Empty EVA Bags recalled?

Potential ability to leak once used for compounding.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code H938739 Lot #'s: 60066021, 60069101, 60072119, 60075857, 60080377, 60084632, and 60095474. **Update expansion on 02/19/2019 with additional lot numbers: 60070846, 60081688, 60097844, 60098902, 60110761, 60110765, 60120570, 60124005, 60124006, 60124008, 60126009.

Product
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient…
Recalling firm
Baxter Healthcare Corporation
Quantity
136,800 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, 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.
Recall date
November 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls