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U.S. Department of Health and Human Services

Class 2 Device Recall ACIST MultiUse Syringe KitModel A2000

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 Class 2 Recall
ACIST MultiUse Syringe KitModel A2000
see related information
Date Posted December 08, 2007
Recall Status1 Terminated on October 06, 2008
Recall Number Z-0359-2008
Recall Event ID 45465
Premarket Notification
510(K) Number
K984231 
Product Classification Injector And Syringe, Angiographic - Product Code DXT
Product ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly)
Code Information Lot Nos: 0037H, 0377K, 0647U, 0877H, 1077K, 3406J, 0037W, 0377L, 0657K, 0887G, 1087F, 3416H, 0197B, 0397T, 0667G, 0937L, 1087B, 3456J, 0197G, 0407F, 0677G, 0947F, 1137F, 3456L, 0227H, 0457G, 0817H, 0997P, 1157J, 3456P, 0227K, 0457H, 0857H, 0997T, 1217M, 3476F, 0247F, 0467G, 0867M, 1007K, 1227B, 0247G, 0647B, 0877B, 1017G, 3106G, 0307B, 0647F, 0877G, 1067F, and 3406H.
Recalling Firm/
Manufacturer
Acist Medical Systems
7450 Flying Cloud Dr Ste 150
Eden Prairie, Minnesota 55344-3720
Manufacturer Reason
for Recall
Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
FDA Determined
Cause 2
DESIGN: Process Design
Action The Urgent Medical Device Recall letter was sent by certified mail to all U.S. base customers on 10/3,4/07. Customers were advised to stop distribution of the product and immediately cease use of the product. Recalled product is to be returned using the FedEx Airbill that was enclosed with the recall letter. Customers were to complete the enclosed "Device Recall Response" form even if they did not have any impacted kits in inventory.
Quantity in Commerce 177,050 Kits
Distribution Nationwide Distribution - including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
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 = DXT and Original Applicant = INVASATEC
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