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U.S. Department of Health and Human Services

Class 1 Device Recall All Med Medical 20ga x .75" Winged Administration Set w/Y Site

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 Class 1 Device Recall All Med Medical 20ga x .75" Winged Administration Set w/Y Sitesee related information
Date Initiated by FirmAugust 30, 2010
Date PostedSeptember 29, 2010
Recall Status1 Terminated 3 on January 31, 2013
Recall NumberZ-2516-2010
Recall Event ID 56548
510(K)NumberK891919 
Product Classification Hypodermic Single Lumen Needle - Product Code FMI
ProductAll Med Medical 20ga x .75" Winged Administration Set w/Y Site Model # M2075Y Reorder # 50-2022
Code Information Lot codes: 5J012A 6A003A 6B056A 6E004A 6E011A 6H052A 6K026A 6L005A 7A016A 7B060A 7C027A 7D001A 7F008A 7I010A 7L026A 8J065A 9E024A 9F020A 9G033A 9H018A 
Recalling Firm/
Manufacturer		 Multi-Med, Inc.
26 Victoria Court
Keene NH 03431
For Additional Information Contactsame
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
ActionMulti-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 Commerce45,537 units
DistributionWorldwide Distribution -- USA and Mexico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMI
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