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U.S. Department of Health and Human Services

Class 2 Device Recall ExactaMix EVA DUAL CHAMBER CONTAINER

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  Class 2 Device Recall ExactaMix EVA DUAL CHAMBER CONTAINER see related information
Date Initiated by Firm September 21, 2018
Create Date October 01, 2019
Recall Status1 Open3, Classified
Recall Number Z-0008-2020
Recall Event ID 83509
510(K)Number K960581  
Product Classification Container, i.V. - Product Code KPE
Product 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.
Code Information Lot Numbers: H938905 63630-A1769, H938905 63630-A1771, H938905 63630-A1773, H938905 63630-A2647, H938905 63630-A2649, H938905 63630-A2651, H938905 63630-A2655, H938905 63630-A2657, H938905 63630-A2659, H938905 63630-A2661, H938905 63630-A3950, H938905 63630-A3952, H938905 63630-A3954, H938905 63630-A3956, H938905 63630-A3957, H938905 63630-A3959, H938905 63630-A3961, H938905 63630-A3963, H938905 63630-A3965, H938905 63630-A3968, H938905 63630- A5338, H938905 63630-A5340, H938905 63630-A5342, H938905 63630-A5344, H938905 63630-A5346, H938905 63630-A5348, H938905 63630-A5350
Recalling Firm/
Manufacturer		 The Metrix Company
4400 Chavenelle Rd
Dubuque IA 52002-2655
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 332640 bags
Distribution US Nationwide distribution including the states of PA, MA, IL CA.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KPE and Original Applicant = SECURE MEDICAL PRODUCTS, INC.
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