| Class 1 Device Recall Acacia IV Extension Set with BD QSyte | |
Date Initiated by Firm | December 18, 2009 |
Date Posted | March 30, 2010 |
Recall Status1 |
Terminated 3 on January 05, 2011 |
Recall Number | Z-1076-2010 |
Recall Event ID |
54181 |
510(K)Number | K895367 |
Product Classification |
IV Extension Set - Product Code FPA
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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 CA 92821-2948
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For Additional Information Contact | 714-257-0470 |
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 | 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 |
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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 = FPA
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