AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 P

FDA device recall Z-0897-2012 · posted 2012-01-26 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LJS

Quantity affected

10 units

Distribution

Nationwide

Date initiated

2012-01-09

Date posted

2012-01-26

Date terminated

2016-02-05

Location

Latham, NY

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