| Class 2 Device Recall ExactaMix EVA DUAL CHAMBER CONTAINER | |
Date Initiated by Firm | September 21, 2018 |
Create Date | October 01, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0007-2020 |
Recall Event ID |
83509 |
510(K)Number | K960581 |
Product Classification |
Container, i.V. - Product Code KPE
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Product | 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. |
Code Information |
Lot Numbers: H938901 63615-A1768, H938901 63615-A1770, H938901 63615-A1772, H938901 63615-A2648, H938901 63615-A2650, H938901 63615-A2652, H938901 63615-A2653, H938901 63615-A2654, H938901 63615-A2656, H938901 63615-A2658, H938901 63615-A2660, H938901 63615-A2662, H938901 63615-A3951, H938901 63615- A3953, H938901 63615-A3955, H938901 63615-A3958, H938901 63615-A3960, H938901 63615-A3962, H938901 63615-A3964, H938901 63615-A3966, H938901 63615-A3967, H938901 63615-A5337, H938901 63615-A5339, H938901 63615-A5341, H938901 63615-A5343, H938901 63615-A5345, H938901 63615-A5347, H938901 63615-A5349 |
Recalling Firm/ Manufacturer |
The Metrix Company 4400 Chavenelle Rd Dubuque IA 52002-2655
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For Additional Information Contact | Dave Wagner 800-752-3148 |
Manufacturer Reason for Recall | Potential for leaking product |
FDA Determined Cause 2 | 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 in Commerce | 175392 bags |
Distribution | US Nationwide distribution including the states of PA, MA, IL CA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = KPE
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