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U.S. Department of Health and Human Services

Class 1 Device Recall All Med Medical 19ga x .75" RA Hub Needle

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  Class 1 Device Recall All Med Medical 19ga x .75" RA Hub Needle see related information
Date Initiated by Firm August 30, 2010
Date Posted September 29, 2010
Recall Status1 Terminated 3 on January 31, 2013
Recall Number Z-2535-2010
Recall Event ID 56548
510(K)Number K891919  
Product Classification Hypodermic Single Lumen Needle - Product Code FMI
Product All Med Medical 19ga x .75" RA Hub Needle
Model #M1975H
Reorder #55-1920

Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
Code Information Lot code: 5I062A 8L038A 
Recalling Firm/
Manufacturer		 Multi-Med, Inc.
26 Victoria Court
Keene NH 03431
For Additional Information Contact same
603-357-8733
Manufacturer Reason
for Recall		 Huber needles may core and result in port leakage or emboli being flushed our of the port.
FDA Determined
Cause 2		 Device Design
Action Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
Quantity in Commerce 4,012 units
Distribution Worldwide Distribution -- USA and Mexico.
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 = FMI and Original Applicant = MULTI-MED, INC.
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