Device Recall Acacia IV Extension Set with BD QSyte 의 리콜

Recall

54181

Class 1

Z-1078-2010

2009-12-18

2010-03-30

Terminated

United States

2011-01-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87774

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.

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.