Z-2096-2016Class I

AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

Name: Z-2096-2016 AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
Creator: Stryker Sustainability Solutions
Published: 2016-06-01
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2016-06-01 / Terminated

FDA source

Stryker Sustainability Solutions began a recall of AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 on 2016-06-01. FDA classified it as Class I and gives the reason as "Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2096-2016
Classification: Class I
Status: Terminated
Initiated: 2016-06-01
Posted: 2016-07-22
Terminated: 2016-10-19
Recalling firm: Stryker Sustainability Solutions
Product: AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
FDA root cause: 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 [email protected], 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2096-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2096-2016	Class I	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-21

Product code DQO

K001578Class IIAngiodynamics Soft-Vu Hydrophilic Coated Angiographic CatheterAngioDynamics, Inc. / cleared 2000-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)