Date Initiated by Firm | August 30, 2010 |
Date Posted | September 29, 2010 |
Recall Status1 |
Terminated 3 on January 31, 2013 |
Recall Number | Z-2536-2010 |
Recall Event ID |
56548 |
510(K)Number | K891919 |
Product Classification |
Hypodermic Single Lumen Needle - Product Code FMI
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Product | All Med Medical 19ga x 1" RA Hub Needle
Model #M191H
Reorder #55-1930
Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port. |
Code Information |
Lot code: 5J008A 9F039A 9F042A |
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 | 4,094 units |
Distribution | Worldwide Distribution -- USA and Mexico. |
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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510(K) Database | 510(K)s with Product Code = FMI
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