Date Initiated by Firm | September 14, 2020 |
Create Date | October 07, 2020 |
Recall Status1 |
Terminated 3 on April 09, 2021 |
Recall Number | Z-0063-2021 |
Recall Event ID |
86503 |
Product Classification |
Angiography/angioplasty kit - Product Code OEQ
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Product | Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - 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 5551869, Exp 01/31/2022 |
Recalling Firm/ Manufacturer |
Medline Industries Inc 3 Lakes Dr Northfield IL 60093-2753
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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 | 20 kits |
Distribution | US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY. |
Total Product Life Cycle | TPLC Device Report |
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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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