Recalls / —

—#50583

Product

EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.

FDA product code

KMK — Device, Intravascular Catheter Securement

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.

Why it was recalled

Sterility of some units may be compromised due to damaged packaging.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.

Recalling firm

Firm

Merit Medical Systems, Inc

Address

1600 West Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

Worldwide, including USA, France, Germany, and United Kingdom.

Timeline

Recall initiated

2007-02-15

Posted by FDA

2007-03-15

Terminated

2011-11-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.