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U.S. Department of Health and Human Services

Class 2 Device Recall Secure, Coram

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  Class 2 Device Recall Secure, Coram see related information
Date Initiated by Firm June 23, 2016
Create Date July 22, 2016
Recall Status1 Terminated 3 on April 11, 2023
Recall Number Z-2263-2016
Recall Event ID 74043
510(K)Number K960581  
Product Classification System/device, pharmacy compounding - Product Code NEP
Product Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
Code Information All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66617, 66622, 66632, 66642, 69616, 69621, 69631, and 69641
Recalling Firm/
Manufacturer		 The Metrix Company
4400 Chavenelle Rd
Dubuque IA 52002-2655
For Additional Information Contact Jennifer Clasen
563-556-8800
Manufacturer Reason
for Recall		 An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
FDA Determined
Cause 2		 Device Design
Action On 6/23/2016, the recalling firm sent written recall notices to their distributors and end users notifying them of the recall. Customers and consignees were instructed to not use the devices, locate and quarantine all affected devices, and to complete the response form.
Quantity in Commerce 18,474 case
Distribution Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NEP and Original Applicant = SECURE MEDICAL PRODUCTS, INC.
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