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
005312011012012111012311012511013011019212023611023811024011024211025912033611042211
- 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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