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U.S. Department of Health and Human Services

Class 1 Device Recall Angiodynamics Soft Vu Omni Flush Catheter

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  Class 1 Device Recall Angiodynamics Soft Vu Omni Flush Catheter see related information
Date Initiated by Firm June 01, 2016
Date Posted July 22, 2016
Recall Status1 Terminated 3 on October 19, 2016
Recall Number Z-2096-2016
Recall Event ID 74301
510(K)Number K001578  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product AngioDynamics Soft Vu Omni Flush Angiographic Catheter
Model Number: 10732203
Code Information Item Lot Manufacturing Number Number Date Expiration Date 10732203 119965U 11/7/2003 N/A 10732203 158623U 12/2/2003 N/A 10732203 175183U 3/22/2005 N/A 10732203 179688U 10/29/2004 N/A 10732203 191185U 12/5/2004 N/A 10732203 210813U 7/1/2005 N/A 10732203 225911U 10/27/2005 N/A 10732203 225918U 10/19/2005 N/A 10732203 225919U 10/17/2005 N/A 10732203 8248U 1/31/2006 N/A 10732203 253202U 2/23/2006 N/A 10732203 277726U 7/21/2006 N/A 10732203 302844U 12/14/2006 N/A 10732203 309329U 11/16/2006 N/A 10732203 325680U 12/30/2006 N/A 10732203 343908U 8/2/2008 N/A 10732203 352756U 8/11/2008 N/A 10732203 352761U 9/3/2008 N/A 10732203 359352U 2/6/2008 N/A 10732203 363987U 5/17/2008 N/A 10732203 366572U 10/18/2008 N/A 10732203 369818U 9/27/2008 N/A 10732203 375883U 9/20/2008 N/A 10732203 772102U 8/5/2004 N/A 10732203 773196U 12/18/2004 N/A 10732203 773216U 1/6/2005 N/A 10732203 775985U 3/16/2005 N/A 10732203 7710750U 8/3/2006 N/A
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact Stryker Sus Sol. Complaint Hotline
888-888-3433 Ext. 5555
Manufacturer Reason
for Recall		 Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action URGENT MEDICAL DEVICE RECALL RESTERILIZED ANGIODYNAMICS SOFT VU OMNI FLUSH ANGIOGRAPHIC CATHETER customer notification letters were sent 06/01/16. Customers were instructed to discontinue use of the recalled product immediately. Customers were told to complete the Recall Effectiveness Check Form and list the affected lots shipped to the facility. The form should be completed, signed, and returned to the local Stryker Sustainability Sales Representative, emailed to ssspfa@stryker.com, or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ 85283 Attn: Jodie Rueckert Customers will receive a credit for all affected devices returned.
Quantity in Commerce 167
Distribution Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.
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 = DQO and Original Applicant = ANGIODYNAMICS, INC.
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