Recall Z-0008-2020 ยท KPE Container, I.V.
The Metrix Company
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
| Date | Sep 21, 2018 |
| Status | Open, Classified |
| Reason | Potential for leaking product |
| Root cause | Process control |
| Action | The Metrix Company notified the direct account (distributors) by telephone on 09/21/2019. The firm asked if the consignees received any complaints of leaking during the divider rod removal and return of any of the lot. The firm expanded the recall and disseminated the notices by email and telephone on 08/2/30/2019. Press was issued on 09/09/2019. |
| Quantity | 332640 bags |
| Distribution | US Nationwide distribution including the states of PA, MA, IL CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960581 | SECURE EVA DUAL CHAMBER MIXING BAG Secure Medical Products, Inc., Apr 30, 1996 |