Recall Z-0936-2013— Bacterin International, Inc.

Name: FDA recall Z-0936-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-28

Class II · Terminated

Class II FDA medical device recall by Bacterin International, Inc., initiated 2013-01-28, terminated 2013-07-08. It names one FDA 510(k) clearance: K063245. Product: Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.. Reason: A portion of a silicone wound drain was found to be cracked..

Recalling firm: Bacterin International, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Terminated: 2013-07-08
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K063245 — ELUTIA COATED CLOSED SURGICAL WOUND DRAINBacterin International, Inc.·cleared 2007-11-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.

Reason for recall

A portion of a silicone wound drain was found to be cracked.

Data sourced from openFDA. This site is unofficial and independent of the FDA.