Recall Z-2096-2016 ยท DQO Catheter, Intravascular, Diagnostic
Stryker Sustainability Solutions
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
| Date | Jul 22, 2016 (initiated Jun 1, 2016) |
| Status | Terminated |
| 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 C |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001578 | ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER AngioDynamics, Inc., Oct 13, 2000 |