Device 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.
Z-0936-2013
Product summary
- Event
- Event 64326
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
- Official record key
device-enforcement:Z-0936-2013
Official wording
Reason: A portion of a silicone wound drain was found to be cracked.
Code information: 005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
Distribution pattern: 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
Derived failure modes
-
Unknown
A portion of a silicone wound drain was found to be cracked.