AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
FDA Recall Z-2096-2016 · Posted 2016-07-22
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Recalling FirmStryker Sustainability Solutions
Recall StatusTerminated
Product CodeDQO
Date Initiated2016-06-01
Date Terminated2016-10-19
Product Quantity167
Reason for Recall
Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
Firm 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.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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