FDAFDA · Food and drugs·Recall number Z-0936-2013
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.
Published March 20, 2013 · Recall initiated: January 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A portion of a silicone wound drain was found to be cracked.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bacterin International, Inc.
- Distributor
- 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
- Lot
- 005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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