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U.S. Department of Health and Human Services

Class 2 Device Recall AT P54 AngioTouch Kit

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  Class 2 Device Recall AT P54 AngioTouch Kit see related information
Date Initiated by Firm June 06, 2008
Date Posted September 23, 2008
Recall Status1 Terminated 3 on January 25, 2011
Recall Number Z-2406-2008
Recall Event ID 49075
510(K)Number K040298  
Product Classification Angiographic Injector and Syringe - Product Code DXT
Product ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico.
Catalogue No: 800608-013

Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Code Information 0368H, 0368J, 0378L, 0388F, 0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T, 0848K, 0848L, 0878M, and 0918N.
Recalling Firm/
Manufacturer		 Acist Medical Systems
7905 Fuller Road
Eden Prairie MN 55344
For Additional Information Contact
952-941-3507
Manufacturer Reason
for Recall		 Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.
FDA Determined
Cause 2		 Package design/selection
Action Consignees were sent a "Urgent: Medical Device Recall" letter dated July 9. 2008. The letter addressed to "Manager" described the Proben and product. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to stop further distribution of that product and immediately cease use of the product. The letter listed the applicable lots and asked customers to verify their inventory against the list. Any inventories matching the lots on the recall list were to be checked on the provided form and the quantity recorded. They were instructed to return the product to ACIST using the provided Air Bill number along with the form, signed and dated. The letters were sent July 10, 2008.
Quantity in Commerce 11,750 (USA), 22,230 (OUS)
Distribution Worldwide Distribution --- USA including states AR, AZ, DC, FL, GA, MS, NC, NE, NH, NY, OH, OK, PA, TX, TN,VA, AL, CA, IL, KS, KY, LA, MD, MN, MO, SD, CO, IA, IN, MI, NV, PR, SC, MI, OR, WV, CT, ND, DC, WA, ME, and NJ, and countries of Canada, Brazil, Japan, China, Korea, Thailand, Hong Kong, and Australia.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DXT and Original Applicant = ACIST MEDICAL SYSTEMS, INC.
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