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U.S. Department of Health and Human Services

Class 2 Device Recall BioStable 5F SL55CM IR145 Kit

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  Class 2 Device Recall BioStable 5F SL55CM IR145 Kit see related information
Date Initiated by Firm May 10, 2018
Create Date June 14, 2018
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-2193-2018
Recall Event ID 80169
510(K)Number K142616  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
Code Information UPN: H965458860; Lot: 5303442
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact David Greer
518-795-1676
Manufacturer Reason
for Recall		 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
FDA Determined
Cause 2		 Material/Component Contamination
Action Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. Complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
Quantity in Commerce 58 boxes
Distribution The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
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 = LJS and Original Applicant = NAVILYST MEDICAL, INC.
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