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U.S. Department of Health and Human Services

Class 1 Device Recall Acacia IV Extension Set with BD QSyte

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 Class 1 Recall
Acacia IV Extension Set with BD QSyte
see related information
Date Posted March 30, 2010
Recall Status1 Terminated on January 05, 2011
Recall Number Z-1076-2010
Recall Event ID 54181
Premarket Notification
510(K) Number
K895367 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Code Information Lot A1950
Recalling Firm/
Manufacturer
Medical Product Specialist Inc dba MPS Acacia
785 Challenger St
Brea, California 92821-2948
Manufacturer Reason
for Recall
Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
FDA Determined
Cause 2
DESIGN: Process Design
Action A letter dated December 18, 2009 was sent to Acacia customers with the following instructions. 1. Immediately review your inventory of Acacia IV Extension Sets with BD Q-Syte for REF numbers and lot numbers listed and remove them from all inventory printed on the unit packaging , shelf box and shelf shipper containers. 2. Complete the Distributor Recall response Card (Attachment 1) and return by fax immediately to the number on the Distributor Recall Response Card for product in your facility at the time of receipt of this letter. This form must be completed and f axed to Acacia, Inc even if there is no product in inventory. 3. Acacia, Inc is currently working to ensure that replacement products are readily available. Once you have identified how much product you will be returning, please call your Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, to arrange for product replacement. Questions are to be directed to the Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, between 8:00AM and 5:00PM MST, Monday-Friday.
Quantity in Commerce 25,132
Distribution US Only
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = MEDICAL PRODUCT SPECIALISTS
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