Device Recall AngioDynamics Morpheus Smart PICC CT 의 리콜

Recall

60909

Class 2

Z-0911-2012

2012-01-09

2012-01-26

Terminated

United States

2016-02-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106954

The red luer on the morpheus ct picc (peripherally inserted central catheter) has the potential to crack during use of the product.

AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product. Complete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax the form to 518-798-1360. If customers distributed the affected product, they should inform their customers of this recall action immediately and have them return the recalled units to them. For any questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.