||March 11, 2013
||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.
||005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
|Bacterin International, Inc.
600 Cruiser Ln
Belgrade, Montana 59714-9719
|For Additional Information Contact
|A portion of a silicone wound drain was found to be cracked.
||Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.
|Quantity in Commerce
||15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
||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.