AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

FDA device recall Z-2096-2016 · posted 2016-07-22 · Terminated

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

Action taken

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

DQO

Quantity affected

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.

Date initiated

2016-06-01

Date posted

2016-07-22

Date terminated

2016-10-19

Location

Tempe, AZ

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