FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
- Recall number
- Z-2096-2016
- Recalling firm
- Stryker Sustainability Solutions
- Product
- AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
- Status
- Terminated
- Initiated
- 2016-06-01
- Posted
- 2016-07-22
- Terminated
- 2016-10-19
- Reason
- Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
- 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 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K001578"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28