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U.S. Department of Health and Human Services

Class 2 Device Recall SECURE EVA DUAL CHAMBER CONTAINER

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 Class 2 Device Recall SECURE EVA DUAL CHAMBER CONTAINERsee related information
Date Initiated by FirmSeptember 21, 2018
Create DateOctober 01, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0003-2020
Recall Event ID 83509
510(K)NumberK960581 
Product Classification Container, i.V. - Product Code KPE
ProductSECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - 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: 66640-A2404, 66640-A4324
Recalling Firm/
Manufacturer		 The Metrix Company
4400 Chavenelle Rd
Dubuque IA 52002-2655
For Additional Information ContactDave Wagner
800-752-3148
Manufacturer Reason
for Recall		Potential for leaking product
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce1512 bags
DistributionUS Nationwide distribution including the states of PA, MA, IL CA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPE
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