Reported Mar 20, 2013 · Terminated

Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver…

Bacterin International, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bacterin International, Inc. · 600 Cruiser Ln · Belgrade, MT · 59714-9719

Is this the product you have?

  • 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.
Lot codes and dates
    • 005312
    • 011012
    • 012111
    • 012311
    • 012511
    • 013011
    • 019212
    • 023611
    • 023811
    • 024011
    • 024211
    • 025912
    • 033611
    • 042211
Amount recalled
15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 8, 2013 · Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.