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U.S. Department of Health and Human Services

Class 2 Device Recall SECURE

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 Class 2 Device Recall SECUREsee related information
Date Initiated by FirmOctober 09, 2024
Date PostedNovember 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0341-2025
Recall Event ID 95499
510(K)NumberK030888 
Product Classification Container, i.V. - Product Code KPE
ProductSECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Code Information UDI/DI 00812496011602, Lot Numbers: 66055-A8336, 66055-A8483
Recalling Firm/
Manufacturer		 The Metrix Company
4400 Chavenelle Rd
Dubuque IA 52002-2655
For Additional Information Contact
563-556-8800
Manufacturer Reason
for Recall		A limited number of IV bags have been found to leak during filling.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe Metrix Company issued an URGENT: NOTICE OFMEDICAL DEVICE RECALL notice to it consignees on 10/09/2024 via email. The notice explained the issue and requested destruction of all affected product. Distributors were directed to notify their customers. For questions, contact: Demitrianna Soppe, Regulatory Affairs Specialist, The Metrix Company, 4400 Chavenelle Road, Dubuque, IA 52002; Telephone: 563-556-8800; E-mail: recall.coordinator@metrixco.com
Quantity in Commerce277 cases of 50 units
DistributionWorldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
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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