ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 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.
FDA Recall Z-0007-2020 · Posted None
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Recalling FirmThe Metrix Company
Recall StatusOpen, Classified
Product CodeKPE
Date Initiated2018-09-21
Product Quantity175392 bags
Reason for Recall
Potential for leaking product
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including the states of PA, MA, IL CA.
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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