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Bacterin International, Inc. recalls Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfad
Recalled March 20, 2013 · FDA recall Z-0936-2013 · Bacterin International
Hazard
A portion of a silicone wound drain was found to be cracked. · FDA Class II
Units
15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Sold at
13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee
Description
A portion of a silicone wound drain was found to be cracked.
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.
Manufacturer(s)
Bacterin International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →