FDA-Device2013-03-20Class II
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.
Bacterin International, Inc.
Hazard
A portion of a silicone wound drain was found to be cracked.
Sold states
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
Affected count
15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Manufactured in
600 Cruiser Ln, N/A, Belgrade, MT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0936-2013Don't want to check this manually?
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