Recall Z-0365-2019
Baxter Healthcare Corporation · initiated September 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 through an intravascular administration set.
Codes / lots: 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.
Reason for recall
Potential ability to leak once used for compounding.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0365-2019
- Initiated
- September 12, 2018
- Posted by FDA
- November 2, 2018
- Terminated
- November 2, 2020
- Product code
- KPE – Container, I.V.
- 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0363-2019 Class II | EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | 09/12/2018Terminated |
| Z-0364-2019 Class II | EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | 09/12/2018Terminated |
| Z-0366-2019 Class II | EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | 09/12/2018Terminated |
| Z-0367-2019 Class II | EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | 09/12/2018Terminated |