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U.S. Department of Health and Human Services

Class 2 Device Recall NAMIC

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  Class 2 Device Recall NAMIC see related information
Date Initiated by Firm September 14, 2020
Create Date October 07, 2020
Recall Status1 Terminated 3 on April 09, 2021
Recall Number Z-0066-2021
Recall Event ID 86503
Product Classification Angiography/angioplasty kit - Product Code OEQ
Product Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Code Information Lot 5551428, Exp 11/30/2022
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
FDA Determined
Cause 2		 Process design
Action Medline Industries, Inc. had provided each consignee with a response form to return via email. Each Response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time. Medline has provided each consignee with a response form to return or email. Each Response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to the field action notification in the allotted time.
Quantity in Commerce 32 kits
Distribution US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
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.
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